Be Fearless

Join our team

Our team is smart, bold and innovative. Thinking about applying? You’re in the right place.

Culture

At RaNA, we are ONE. We’re diverse, yet united in our mission to change the treatment paradigm for patients living with genetic diseases. We stick to our values.

We work hand in hand with our leaders to encourage new ways of thinking.

In the seriousness of our mission, we also understand we are people and like to have fun together. From bonding during lunch to new discoveries in the lab that lead us that much closer to helping people, there’s always something to look forward to each day at RaNA. Our story is best told by the very people who live and breathe our science and mission every day: our fearless employees.

Quote-John

“It’s all about the anticipation. Each day I wake up knowing we are one step closer to a breakthrough medicine.”

- John Androsavich, Senior Scientist

Quote-Elizabeth

“I work with incredibly driven and intelligent individuals, who constantly challenge me and allow me to develop further as a scientist.”

- Elizabeth Wu, Research Associate

“We are developing completely novel approaches for upregulating gene expression with the ultimate goal of improving the lives of patients.”

- Brian Schwartz, Scientist

Quote-Brian (1)

“The employees here are extremely intelligent and enthusiastic about our science, which makes coming into work every day fun and exciting.”

- Amy Iannelli, Manager of Finance and External Reporting

Quote-Amy

Opportunities

If you are interested in joining our RaNA team, please review the openings below and submit your resume to careers@ranarx.com with the job title in the subject line.

Research Associate/Senior Research Associate, Screening and Core Technologies

We are currently seeking a highly motivated, rigorous and talented Senior Research Associate or Research Associate to join our Screening and Core Technology group.  The Screening and Core Technology group covers screening, internal next generation screen activities, CRISPR based gene editing efforts, and the growth, maintenance, and differentiation of iPSCs or primary cells in 2D, 3D, and organoid cultures. This position will be primarily responsible for in vitro RT-qPCR based screening to support our new liver target platform. This person will also act as the lab manager for the Biology teams at RaNA and coordinate shipping and stocking through external vendors.  Additional responsibilities may also include support for CRISPR gene editing, cross-training for the Next-Gen screening, development and validation of new gene expression panels, and validation of protein expression and functional analysis. She/he has demonstrated capability to work independently as well as in team setting.

Required Experience, Education and Capabilities

  • BS/MS degree in biology, biochemistry or related area and an understanding of molecular biology and tissue culture techniques.
  • Must have hands-on experience screening compounds in cell based assays, including mammalian cell culture, transfections, and RNA and protein analysis, working with 96 and 384-well formats and multichannel pipettes, and be comfortable working at mid to high throughput
  • Experience with cellular and molecular biology techniques is required, including RNA and protein isolation, qRT-PCR, ELISA, western blotting, RNAi approaches, tissue handling, and in vitro systems.
  • Experience with oligos, HCC cell lines, Cell to Ct RNA isolation reagents, lipid based transfection reagents, and the Viaa7 qPCR machine is desired.
  • Experience with next generation library preparation and sequencing is a plus.
  • Strong data analysis skills are required.
  • Demonstrated ability to troubleshoot technical assays, instruments and protocols.
  • Ability to multitask and work independently and collaboratively as part of an interdisciplinary team in a matrix environment with 15-20 scientists. Excellent organizational and time management skills, the ability to generate high quality data under tight deadlines.
  • Excellent organizational and communication skills to participating in multiple projects in a matrix research organization. He/she should have the ability to present data and share insights with team members on selected project teams and to the communicate the impact of their work to a larger audience, not only within RaNA but to the greater scientific community as well.

Senior Scientist, Manufacturing Sciences and Technology

We are seeking a highly motivated and scientifically rigorous individual to join our team as a Senior Scientist.  The successful candidate will report to the Senior Director, Manufacturing and be an integral part of the MRT production team. The position will focus on drug substance and drug product manufacture, regulatory and analytical support, including development, validation, and data review for drug substances and drug products.  The position will help develop scalable and robust formulation processes for drug substance and drug product and serve as the process knowledge link between Process Development and drug substance and drug product manufacturing.

Key Skills and Competencies

  • Coordinate technology transfer of mRNA and nanoparticle manufacturing processes.
  • Demonstrated expertise in process development/scale-up of drug product formulation.
  • Design and conduct experiments to investigate the impact of formulation parameters on drug product processes.
  • Identify solutions, including process analytical technologies which lead to robust process control strategies.
  • Ability to provide technical support and resolve scale-up and manufacturing issues, develop solutions to improve process efficiency and product quality.
  • Prepare technical reports and presentations that support scale-up activities and process improvements.
  • Support and contribute to IND filings/regulatory documentation

 Qualifications

  • Chemistry, Chemical engineering or Biochemistry BS/MS with 12+ years of experience or PhD with 6+ years of experience in pharmaceutical or biotechnology company.
  • Demonstrated success in nucleic acid delivery and the development of novel drug carriers with hands-on technology transfer experience in lipid nanoparticle (LNP) and polymer-based nanoparticle formulations.
  • Experience with analytical tools for release and characterization of drug product processes and drug products.
  • Demonstrated ability to apply fundamental scientific and engineering skills to evaluation of processes and development of practical solutions to technical challenges.
  • Strong familiarity with cGMP, ICH and regulatory guidelines
  • Ability to work with CROs/CMOs
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Operational execution and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Project Manager, Portfolio and Program Management

 

We are searching for a highly motivated individual to join the RaNA team as a Project Manager. The successful candidate will partner with the Sr. Director of Program Management to prepare critical data for governance presentations, proactively manage timelines, budgets and assist in the analysis of options across the portfolio. He/she will play a role in the continuous optimization of the portfolio and program management function to support organizational growth as assets move from research/development through the clinic, and will also assist with the day to day management of key activities associated with highly functioning project teams, including the identification, tracking and management of critical activities to ensure programs progress as planned. In addition, the project manager will be responsible for creating and managing various project plans, establishing agendas, minutes etc. and working closely with functional leads to ensure accurate, timely project updates that will drive key decisions.

Key Competencies

  • Candidate will have a minimum of 3-5 years direct experience in a biotechnology organization and a proven ability to work cross functionally at all organizational levels.
  • Strong interpersonal skills, self-awareness and ability to manage team dynamics. Displays a high degree of integrity, enthusiasm and operates from a frame work of possibility.
  • Demonstrated success with handling multiple projects coupled with a strong knowledge of the discovery and development process.
  • Must be motivated, creative, energetic and adaptable, responding constructively to challenging new ideas, information and situations.
  • Excellent organization skills with great attention to detail and a desire to grow within a dynamic, fast paced biotechnology organization.
  • Individual is driven by a sense of urgency to develop therapies for patients with significant unmet medical needs.

Requirements

  • BS/MS/PhD in scientific discipline and/or MBA with relevant 3-5 years of biotechnology experience.
  • Fluency in written and spoken English is required.
  • Excellent knowledge with all aspects of MS Office including Visio and MS Project.
  • Domestic and occasional international travel may be required.
  • PMP certification preferred but not required.
  • Only candidates with demonstrated experience as described in the role summary will be considered for this highly visible role.

Project Manager

We are seeking a highly motivated and organized individual to join our team as a Project Manager.   The successful candidate will report to the Sr. Director of Manufacturing and be an integral part of the CMC team.  This position offers opportunities to work with multiple external CROs and CMOs in addition to the RaNA Therapeutics team.  The successful candidate will be responsible for management of multiple external CMC-related projects.

Primary Responsibilities

  • Manage CMC projects outsourced to multiple CROs / CMOs. Collaborate with internal and external teams to set priorities, plan activities, monitor progress, make decisions, resolve issues and identify risks and mitigation plans.
  • Track timelines, milestones and deliverables for outsourced projects to provide input into overarching program plan.
  • Manage inventory of multiple raw materials required for drug substance and drug product production. Coordinate with multiple vendors to order required raw materials and monitor outstanding deliveries.
  • Review and approve project/product related documentation including protocols, reports, procedures and specifications.
  • Assist in compilation of CMC information to support IND applications.
  • Assist in the development of new contracts with external CROs / CMOs. Track invoices against purchase orders.  Assist with budget planning and development.

Qualifications

  • Bachelor’s or Master’s degree in life sciences or engineering.
  • 5-8 years (Bachelor’s) / 3-5 years (Master’s) experience in a similar position, 5-10 total years’ experience in the biotechnology / pharmaceutical industry.
  • Demonstrated success in managing multiple projects effectively.
  • Ability to effectively represent the Company to external CROs and CMOs.
  • Knowledge of product development process including typical Chemistry, Manufacturing and Controls (CMC) activities.
  • Experience with analytical method development and qualification, process development, and cGMP manufacturing and release.
  • Desire to work in a fast-paced environment.
  • Excellent organizational and communication skills.
  • PMP certification desirable.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Associate Scientist, MRT Biologist (In Vitro/In Vivo)

We are seeking a highly motivated and scientifically rigorous individual to join our team as an Associate Scientist. The successful candidate will report to the Associate Director/Group Leader and be an integral part of the MRT team.  This position offers opportunities to discover, create and research new mRNA-based drug therapeutics for the treatment of a wide array of genetic diseases.  The successful candidate will be responsible for supporting full characterization of mRNA therapeutic candidates through a wide range of analysis of in vitro and in vivo studies.  Further, development of key assays for biological detection of both mRNA and protein targets, characterization of drug substance material as well as other critical responsibilities will be expected of a successful candidate.

Primary Responsibilities

  • Support all in vitro and in vivo analysis for the detection, characterization, quantification and activity of both mRNA target drug substances as well as specific protein targets.
  • Conduct biological assays such as ELISA, western blot, gel electrophoresis supporting lead programs
  • Maintain multiple cell lines for tissue culture using proper aseptic techniques
  • Perform critical analyses for in vivo studies spanning multiple lead programs
  • Develop & conduct new assays for characterization of target protein
  • Prepare technical reports and makes recommendations based on research outcomes

Qualifications

  • M.S. in Biology or Biochemistry
  • 6-10 years of industrial experience preferred
  • Strong knowledge and execution of assay development (ELISA, enzyme activity, western blot, silver stain, etc.) for protein detection and quantification is imperative for success
  • Extensive experience in maintaining multiple cell lines simultaneously under minimal supervision is required
  • Ability to design, conduct and analyze transfection-based studies involving nucleic acids
  • Previous work with mRNA (handling/isolation/quantification/characterization) is highly desired and would be considered over other candidates
  • Demonstrated record of successful in vitro/in vivo analysis supporting lead programs including proper tissue handling, homogenization, protein/RNA isolation, etc.
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Associate Scientist, Process Development & Biological Characterization

We are seeking a highly motivated and scientifically rigorous individual to join our team as an Associate Scientist, mRNA Process Development and Biological Characterization. The successful candidate will report to the Associate Director/Group Leader and be an integral part of the MRT team.  This position offers opportunities to discover, create leading mRNA production processes providing crucial drug substance material applicable for the treatment of a wide array of genetic diseases.  The successful candidate will be responsible for supporting mRNA process development for our MRT platform encompassing the development of the largest scale mRNA production in the industry, optimization of current small scale mRNA batch production, full characterization of drug substance material as well as other critical responsibilities.

Primary Responsibilities

  • Support mRNA process development efforts for multiple mRNA drug targets entailing: large-scale batch production, batch record execution/maintenance, optimization of mRNA processes (enzymatic/physical/analytical)
  • Provide accurate and reproducible execution of analytical characterization for full release panel for mRNA drug substance
  • Conduct biological assays such as ELISA, western blot, gel electrophoresis supporting lead programs
  • Prepare technical reports and makes recommendations based on research outcomes

Qualifications

  • M.S. in Biology, Biochemistry, Engineering
  • 6-10 years of industrial experience preferred
  • Demonstrated success in nucleic acid synthesis/handling(RNase-Free)/application with hands-on experience in messenger RNA production/characterization (required)
  • Further experience with process development/scale-up and a working knowledge of batch record documentation is highly desired
  • Familiarity with GMP operations is preferred
  • Strong disposition for analytics (QC, methods, assay development)
  • Ability to conduct routine biological assays including ELISA, western blot, silver stain, gel electrophoresis, etc. would be preferred
  • Handling/analysis of in vitro/in vivo tissue and serum samples is advantageous
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Principal Development Scientist, Manufacturing Sciences & Technology

We are seeking a highly motivated and scientifically rigorous individual to join our team as a Principal Development Scientist. The successful candidate will report to the Senior Director, Manufacturing and be an integral part of the MRT team. The position will focus on drug substance and drug product manufacture, drug formulation, regulatory and analytical support, including development, validation, and data review for drug substances and drug products.

Will also provide technical support to the MRT team for the pharmaceutical development of RaNA’s Messenger RNA Therapeutics lead candidates.  The position will help develop scalable and robust formulation processes for drug substance and drug product and serve as the process knowledge link between Process Development and drug substance and drug product manufacturing.

Primary Responsibilities

80%

  • Provide technical leadership for drug product development and tech transfer activities.
  • Author/review development documents and support IND regulatory submissions
  • Represent within cross functional project teams including process development, CMC and tech transfer teams
  • Will provide support in laboratory to Process Development team when needed as it relates to manufacture of DS or DP.          
  • Manages and oversees the development of drug substances and drug formulations and/or transfer of development activities with RaNA contractors.
  • Provides technical input for selecting external RaNA contractors as well as managing the day-to-day contractor activities with MRT Program Managers.
  • Leads drug /device compatibility assessment activities.
  • Works closely with GMP manufacturers of drug products and drug substances.
  • Writes/reviews protocols and performs batch record review for manufacturer of drug substances and drug products.
  • Writes/reviews analytical method protocols and stability protocols.
  • Writes CMC and drug/device compatibility documents to support IND filings.
  • Provides any necessary support to line manager as required

20%

  • Assists in the review and evaluation of CMC documents during a due diligence exercise.
  • Uses DOE and QbD principles in developing robust API and Finished Product manufacturing processes

Key Skills and Competencies

  • The principal development scientist position will work closely with groups within MRT including Process and Analytical Development as well as external contract organizations, and participate /lead tech transfer teams and work with CMO on cGMP manufacture and release of drug product.
  • Extensive experience and demonstrated track record in biopharmaceutical development including but not limited to formulation development, drug product development, drug product process characterization and validation.
  • In-depth understanding of nucleic acid drug development, formulation, delivery systems and drug/device characterization.
  • Must be well-organized and self-motivated, and possess an independent work style.
  • Ability to lead effectively and concurrently on multiple projects in a goal-oriented, timeline-driven, and dynamic work environment while ensuring quality and accuracy.
  • Proactively identify potential issues and develop creative solutions to technical problems to keep projects on schedule.
  • Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside RaNA.

Qualifications

  • Ph.D. degree in pharmaceutical chemistry, biochemistry, engineering or related disciplines.
  • Minimum of 8 years of experience in pharmaceutical development and manufacturing of nucleic acid-based therapeutics.
  • Experience with PD/mfg, release testing, formulation development, drug/device characterization

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Research Specialist II/Sr. Research Specialist – Drug Delivery

We are seeking a highly motivated and scientifically rigorous individual to join our team as a Research Specialist II/Sr. Research Specialist.   The successful candidate will report to the Associate Director/Group Leader and be an integral part of the MRT Drug Delivery team.  This position offers opportunities to discover, formulate and support leading mRNA formulations for the treatment of a wide array of genetic diseases.  The successful candidate will be responsible for supporting key formulation development for our MRT platform encompassing in vitro/in vivo mRNA formulation screening, routine characterization of both drug substance (nucleic acid payload) and drug product as well as other critical responsibilities.

Primary Responsibilities

  • Support laboratory formulation development of mRNA drug targets entailing: production of LNP/polymer-based nanoparticles for in vivo studies, formulation characterization, and assay development
  • Contribute to scale-up activities for large scale production of RNA drug product (support/conduct scaled-up formulation processes to establish successful drug product process development, batch record analysis)
  • Provide formulations and perform characterizational assay support/data analysis for CROs with focus on in vivo studies, drug carrier design/development, assay development
  • Prepare technical reports and makes recommendations based on research outcomes

Qualifications

  • B.S/M.S in Chemistry, Chemical engineering or Biochemistry
  • 4-6 years (B.S.) or 2-4 years (M.S.) of industrial experience preferred
  • Demonstrated success in nucleic acid delivery with hands-on experience in lipid nanoparticle (LNP) formulations, polymer-based nanoparticles & characterization (required)
  • Direct experience with messenger RNA encapsulation/characterization/handling is preferred
  • Further experience with process development/scale-up and familiarity with batch record documentation is highly desired
  • Proficiency in analytical techniques (HPLC/UPLC, DLS, CD, zeta potential, UV-Vis and fluorescence spectrophotometry)
  • Demonstrated understanding and success in implementation of RNA-related analytics (Ribogreen, gel electrophoresis, capillary electrophoresis, etc.)
  • Experience in developing lyophilized formulations is a plus
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Scientist, Drug Delivery & Process Development

We are seeking a highly motivated and scientifically rigorous individual to join our team as a Scientist.   The successful candidate will report to the Associate Director/Group Leader and be an integral part of the MRT Drug Delivery team.  This position offers opportunities to discover, formulate and create leading mRNA formulations for the treatment of a wide array of genetic diseases.  The successful candidate will be responsible for supporting key formulation development for our MRT platform encompassing in vitro/in vivo mRNA formulation screening, nanoparticle design and characterization, new delivery modalities and applications as well as other critical responsibilities.

Primary Responsibilities

  • Lead laboratory formulation development of mRNA drug targets entailing: production of LNP/polymer-based nanoparticles for in vivo studies, formulation optimization and characterization
  • Support scale-up activities for large scale production of RNA/carrier drug product (design, execution, batch record production/analysis)
  • Manage outside relationships with CROs with focus on in vivo studies, drug carrier design/development, assay development
  • Develop alternate formulations tailored for various routes of administration
  • Prepare technical reports, presentations, etc. for clear communication of scientific findings to cross-functional groups

Qualifications

  • Ph.D. in Chemistry, Chemical engineering or Biochemistry
  • 1-3 years of industrial experience preferred
  • Demonstrated success in nucleic acid delivery and the development of novel drug carriers with hands-on experience in lipid nanoparticle (LNP) formulations, polymer-based nanoparticles & characterization (required)
  • Direct experience with messenger RNA encapsulation/characterization/handling is preferred
  • Further experience with process development/scale-up is highly desired
  • Working knowledge of organic chemistry and its applications to drug delivery (required)
  • Previous experience designing successful drug products for various routes of administration (subcutaneous, intramuscular, pulmonary, CNS, etc.)
  • Familiarity with lyophilization theory and techniques
  • Strong disposition for analytics (QC, methods, assay development)
  • Demonstrated experience in working with outside CROs/CMOs
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

 

 

 

 

 

Associate Director, Regulatory Operations

We are seeking a highly motivated and scientifically rigorous individual to join our team as Associate Director, Regulatory Operations. The successful candidate will report to the Chief Scientific Officer and be an integral part of the R&D team. This position offers opportunities to develop and execute the global regulatory strategy for a portfolio of mRNA-based therapies. The successful candidate will be responsible for developing and directing global regulatory strategy; planning, overseeing and delivering all regulatory filings; and managing all interactions and meetings with regulatory agencies.

Primary Responsibilities

  • Develop and direct the global regulatory strategy and objectives for multiple mRNA-based therapeutics. As the regulatory lead, represent regulatory on all key internal decision-making teams and on all external interactions with regulatory agencies.
  • Based on technical and regulatory knowledge, provide proactive guidance to internal teams on the development of strategic plans, specifically to identify and assess regulatory risks associated with different strategies; and help internal teams problem-solve complex regulatory and clinical issues, and generate options for decision-making.
  • Lead the development and submission of regulatory documents, e.g., pre-IND and end-of-Phase 2 briefing books, INDs, NDA/BLAs, CTAs, MAAs, and other relevant regulatory filings (responses to regulatory queries, IND safety reports).
  • Lead and facilitate meetings with regulatory agencies and prepare internal teams for these interactions.
  • Clearly communicate the regulatory strategy and deliverables to project teams, and proactively drive project teams and external vendors to meet the designated timelines for deliverables.

Qualifications

  • BA, BS, MA, MS, PhD, MD in science or healthcare preferred, or equivalent relevant experience.
  • At least 8-10 years of regulatory affairs or equivalent experience. The regulatory experience should be sufficiently broad to ensure appropriate regulatory leadership for all stages of development.
  • Demonstrated success in guiding the development of new investigational products, spanning preclinical through Phase 3 clinical development.
  • Hands-on experience in the preparation of regulatory filings, including preparation of INDs and NDAs/BLAs, and pre-IND and end-of-Phase 2 meeting materials.
  • Experience with FDA and EMA interactions, and interactions with other global regulatory agencies highly preferred. Experience in conducting face-to-face and teleconference meetings with regulatory agencies.
  • Strong competency in understanding global regulatory requirements and emerging changes in the global regulatory landscape.
  • Strong analytical and problem-solving skills; specifically, to analyze and interpret scientific and clinical data, and to problem-solve complex regulatory and clinical issues.
  • Ability to present complex issues in oral and written form.
  • Excellent organizational skills.
  • Desire to work in a fast-paced environment.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Senior Administrative Assistant

We are seeking highly motivated and team-oriented Senior Administrative Assistant to join RaNA.  The Senior Administrative Assistant will provide support to the R&D leadership team. Daily activities require thorough knowledge of company operations, policies and procedures.  This role involves handling details of a highly confidential and critical nature, and collecting and preparing information for use in discussions/meetings of executive staff including Strategic Advisory Board and Board of Directors, as well as outside individuals. Must be a detail-oriented self-starter with the ability to manage multiple projects simultaneously. Must have excellent interpersonal skills to work effectively with all levels of the organization and high-level external contacts.

Key Responsibilities

  • Calendar management: Manage calendars of R&D leadership with keen attention to detail, schedule meetings and interviews, arrange travel and oversee related logistics, and manage expense reporting process.
  • Meeting planning: Responsible for department meeting planning and organization (schedule attendees, set up conference line for remote attendees, book conference rooms, arrange catering, prepare presentations, meeting materials, book travel for external guests, etc). This includes weekly research meetings, Scientific Advisory Board meetings, and other R&D-focused meetings.
  • Document organization: Responsible for developing and maintaining filing systems, both hard copies (as appropriate) and electronic copies on the corporate file share with guidance from R&D leadership. Serve as the first point of contact for new/renewed contracts, maintaining an index of ongoing contracts/expiring contracts, in support of the General Counsel. Manage the shipping permit process in collaboration with the Director of Facilities.
  • Lab supply ordering: Responsible for managing ongoing/recurring bulk lab orders, working closely with the R&D organization to understand ongoing needs and forecast future orders.
  • Scientific publication library maintenance: Maintain RaNA’s scientific publication library and purchases. Assist in the distribution of relevant materials as needed, and handle incoming requests from the R&D team for archived documents.
  • Additional R&D support: As needed, support R&D management in preparing and editing presentations. Proactively respond to questions, concerns, and requests for information and resolve routine questions and information requests.
  • Administrative support: As needed, serve as back-up support to the office manager and executive assistant. This may include covering the front desk, greeting guests, and directing calls accordingly to ensure smooth day-to-day operations.

Requirements

  • Bachelor’s degree
  • 5+ years administrative experience; Pharmaceutical industry experience highly preferred
  • Highly proficient in Microsoft Office packages including MS Outlook, Word, Excel, PowerPoint
  • Excellent oral and written communication, time management and organization skills
  • Travel/meetings management experience
  • Ability to handle highly confidential information with discretion
  • Experience supporting more than one person preferred

 

 

Clinical Program Lead (Associate Director/Senior Manager)

We are seeking a highly motivated and scientifically rigorous individual to join our team as Clinical Program Lead. The successful candidate will report to the Vice President of MRT Clinical Operations and be an integral part of the MRT team. This position offers the opportunity to have a primary role in the clinical development of a portfolio of mRNA-based therapies. The successful candidate will be responsible for the strategic and operational oversight, management, and delivery of all clinical studies in the program.

Primary Responsibilities

  • Responsible for the strategic and operational aspects of the clinical studies in the development program for multiple mRNA-based therapeutics. As the Clinical Program Lead, provides functional input into the clinical development plan that is consistent with the goals of the program.
  • Authors, provides input, and/or oversees program and/or study documents.
  • Manages clinical outsourcing and is the representative on CRO and other vendor oversight teams.
  • Manages financial aspects of studies, including CRO and investigator budgets. Provides critical review of contracts and/or work orders, and oversees ongoing performance of CROs and other vendors.
  • Collaborates with project physician, data manager and statistician, and other relevant functional areas on clinical trial design and CRF generation.
  • Oversees study level document generation (e.g., clinical study reports, ICFs, trial submissions to regulatory agencies, pharmacy and lab manuals).
  • Participates in the selection of investigational sites with project physician.
  • Ensures clinical trial site’s adherence to pertinent regulations. Leads ongoing review of data to ensure GCP.
  • Clearly communicate the clinical development strategy and deliverables to project teams and external vendors, and proactively drive project teams and external vendors to meet the designated timelines for deliverables.

Qualifications

  • Bachelor’s degree or nursing qualification is required. Scientific/healthcare field preferred but not required. Advanced degree preferred.
  • Significant clinical research experience (at least 8 years) with evidence of increasing responsibility in a pharmaceutical company or CRO. Clear and thorough understanding of all aspects of clinical trial conduct. Global clinical trial experience is required.
  • Detailed knowledge of current regulatory requirements and guidelines governing clinical research.
  • Participation in IND and NDA/BLA submissions is preferred.
  • Experience leading cross-functional teams.
  • Excellent communication and organizational skills.
  • Desire to work in a fast-paced environment.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

Senior Scientist: Chemistry-Drug Delivery

We are seeking highly motivated and scientifically rigorous individual at the Sr. Scientist level to join the RaNA.  The successful candidate will report to the Head of Chemistry and be an integral part of the team.

Responsibilities:

  • Develop oligonucleotide delivery strategies to expand the opportunities to extrahepatic tissues
  • Independently search existing literature and build a strong knowledge of the RNA therapeutics delivery field
  • Optimize and develop effective targeted ligand oligonucleotide conjugation chemistries
  • Demonstrate creativity by identifying new chemical entities as a part of developing novel delivery strategies
  • Exhibit attention to detail in generating and analyzing high quality data
  • Demonstrate high proficiency in technical and operational aspects of mass spectrometry and HPLC, FPLC, NMR, UV/Vis spectroscopy
  • Identify and build relationships with external collaborators to explore new and novel delivery modalities
  • Work closely and effectively with supervisor to make critical decisions

Requirements:

  • Ph.D. in chemistry, organic chemistry or pharmaceutical science
  • 6+ years of industry experience following post-doc
  • 2-3 years of industrial experience in drug delivery systems, preferably oligonucleotides
  • Experience in conjugation chemistry is a plus
  • Highly skilled in structure elucidation of small molecules including nucleosides, lipids and carbohydrates
  • Hands-on experience in mass spectrometry and HPLC, FPLC, NMR, UV/Vis spectroscopy
  • Excellent written and verbal communication skills to interact within the organization and external collaborators
  • Must be able to work in a fast-paced environment, prioritize, and multitask
  • Must demonstrate the ability to meet aggressive timelines
  • Highly motivated, enthusiastic and able to work independently

To apply, please email your CV to careers@ranarx.com.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S. RaNA has a competitive employee benefits package that includes health/dental insurance, 401K retirement plan and company match, paid vacation, and much more!

 

Head of Intellectual Property

RaNA Therapeutics is seeking a Head of Intellectual Property to play a key role in our growing organization. The Head of IP will assume primary responsibility for management and strategy of in-house intellectual property matters. In this role, you will work closely with RaNA’s senior leadership, scientists and outside IP counsel to develop RaNA’s intellectual property strategy. The ideal candidate will be action-oriented, possess excellent collaboration and communications skills, and will thrive in an interactive, dynamic, team-oriented culture.

The Head of IP must have the ability to work cross-functionally with internal stake holders and external collaborators to lead and manage a variety of responsibilities. The successful candidate will review and draft patent applications for ideas and inventions arising from RaNA scientific staff, manage RaNA’s outside IP counsel, represent RaNA’s IP interests in third party collaborations or license agreements and provide strategic counsel on freedom to operate.

Primary Responsibilities

  • Provide strategic direction to outside counsel on patent filing and prosecution matters on a global basis
  • Provide patentability and FTO opinions in support of R&D project teams; assist with IP related due diligence, review and agreement negotiation to support investment, partnering and in-licensing activities
  • Identify patentable inventions through frequent interactions with R&D project teams, create appropriate patent protection strategies and execute on those strategies
  • Coordinate and perform FTO and patentability searches to ensure FTO for RaNA’s products and technology
  • Manage the intellectual property and relationships for RaNA’s academic licensors and collaborators
  • Ensure RaNA’s compliance with its academic licenses, including diligence reporting
  • Track and analyze the relevant patent literature from various companies and academic institutions that may be competitors of RaNA
  • Assist or lead, as appropriate, the negotiation and drafting of agreements with IP implications
  • Develop and present materials on relevant laws and legal/business issues

Minimum and Preferred Qualifications

  • J.D. from an accredited U.S. law school and licensed to practice law in Massachusetts
  • Degree in biology, chemistry or life sciences; advanced degree preferred
  • 5+ years of experience with patent drafting, strategy and prosecution with life science companies
  • Experience in both law firm and in-house settings (life sciences company)
  • Experience with biologics IP highly preferred
  • Experience negotiating partnership agreements preferred
  • Transactional experience in drafting and negotiating a wide range of agreements including patent licenses, confidentiality agreements, material transfer agreements and sponsored research agreements preferred
  • Excellent judgment; ability to assess risks and benefits and convey them in a clear and concise manner

Head of Pharmacology

 

We are seeking a highly motivated and scientifically rigorous individual to join RaNA and lead our Pharmacology efforts.  The successful candidate will report to Head of Translational Development and will be an integral part of the Research and Development team.

Summary of Role

The Head of Pharmacology is responsible for providing pharmacology strategy, expertise, representation and resources to all program teams and RaNA management across all therapeutic areas and stages of development.  S/he will provide leadership and oversight of the Pharmacology group and will work closely with Discovery, Chemistry, Regulatory and Clinical colleagues to generate and  integrate in vitro and in vivo pharmacology and pharmacogenomic data leading to the demonstration and confirmation of pharmacologic target engagement, mechanism of action (MoA) and proof of concept (PoC) efficacy or pharmacodynamic effect for novel therapeutics in translationally relevant disease models.  In addition, the pharmacology organization will be responsible for exploration and validation of biomarker strategy, identification and validation, as well as study design, analysis and reporting for all phase-appropriate and registration-enabling studies. The successful group leader is expected to maintain a flat, consensus-driven team and to balance big picture, long-term and strategic considerations with tactical, detailed technical aspects in approaching and dealing with program-related pharmacology issues. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The Head of Pharmacology develops and implements strategic plans for preclinical Pharmacology and actively participates in program teams, providing expert representation to global regulatory agencies as well as collaborating with R&D leadership and assisting in the identification of new business initiatives and in-licensing opportunities. The successful candidate will establish and maintain appropriate quality systems and procedures for outsourcing, managing and reporting for Pharmacology studies and other activities in support of RaNA portfolio programs, and provide submission-ready documentation for the Pharmacology components of regulatory submissions.

Key Competencies

  • A broad understanding of the drug development process and the ability to provide expert guidance in designing and implementing nonclinical Pharmacology studies and development programs for biopharmaceuticals including protein therapies, antibodies, oligonucleotides and small-molecule therapeutics.
  • Demonstrated knowledge of global regulatory requirements and expectations for nonclinical Pharmacology packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
  • Ability to analyze, interpret and document nonclinical Pharmacology and PK/PD data with overall responsibility to ensure that sufficient preclinical knowledge exists to validate the mechanism of action (MoA) for clinical and regulatory purposes prior to human administration.
  • Experience within a team environment as both a member and a leader with strong organizational and interpersonal skills, including exceptional oral and written communication skills with a demonstrated ability to write protocols, nonclinical/clinical study reports and scientific peer-reviewed publications.
  • Ability to influence through effective communication, respectful challenge, and persuasion across the Research and Development organization is essential.
  • Ability to effectively represent the Company to key external stakeholders, effectively engage and present to staff at all levels, including senior management and technical and business experts clearly and at the appropriate level of detail in representing strategy, results and implications.
  • Demonstrate and maintain comprehensive cross-functional and industry perspective, judgement and ability to apply understanding to individual projects and programs. 

Requirements

  • PhD in a related subject, preferably Pharmacology.
  • 8-10+ years industry-related experience in Pharmacology working within the biotechnology or pharmaceutical industry, including previous work with nucleic acid therapeutics.
  • Extensive training in pharmacokinetic analysis and biostatistics, including development and validation of disease models (eg, liver/metabolic, kidney, ocular, inflammation/immunology, neuromuscular, genetic disease).
  • Hands-on experience in all aspects of Pharmacology study conduct, including: study design, execution interpretation and reporting, in vitro/in vivo, methods, animal models, advanced data analysis, modeling/simulation, reporting and compliance.
  • Experience authoring relevant sections of regulatory documents and providing expert representation to global regulatory agencies in support of submissions at all stages of development, ie, IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA.
  • Extensive experience in the outsourcing and external oversight of Pharmacology studies conducted by qualified suppliers.
  • Experience in providing formal scientific/technical due diligence support for Business Development activities is required.
  • Evidence of leadership within the industry, eg such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
  • Must be motivated, creative, energetic, resourceful and adaptable, responding constructively to challenge, new ideas, information, situations or criticism.
  • Must be able to balance big picture thinking with fine detail level analysis and have demonstrated ability in problem solving as applied to drug development and program/functional management.
  • Fluency in written and spoken English is required.
  • Domestic and occasional international travel required.

 

 

 

Head of Translational Development

We are seeking a highly motivated and scientifically rigorous individual to join RaNA and lead our Translation Development efforts.  The successful candidate will report to the Chief Scientific Officer and be an integral part of the Research and Development Leadership team.

Summary of Role

 The Head of Translational Development will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. S/he must be capable of representing the Company externally in all technical matters, collaborating with other R&D leadership and external alliance partners or collaborators and assisting in the identification of new business initiatives and in-licensing opportunities. The successful candidate will be responsible for design and implementation of Translational Development strategy, providing support and guidance to early preclinical and clinical programs through registration and commercialization.  In addition, s/he will effectively lead and manage the Translational Development department, comprised of Pharmacology, Pharmacokinetics and Drug Metabolism, Toxicology, Bioanalysis and Biomarkers, ensuring that resources are applied appropriately, that Translational Development functions have the leadership, experience and expertise needed to deliver on their goals and that the internal versus external resource balance is maximized. The Head of Translational Development will also establish and develop a broad network of external collaborators in order to maintain cutting edge core competencies, facilitate a proactive outsourcing strategy, and identify novel preclinical development strategies and approaches and to keep abreast of the regulatory environment.

Key Competencies

  • A broad understanding of the drug development process (both large & small molecule) and the ability to provide expert guidance in designing and implementing comprehensive translational development programs for biopharmaceuticals including protein therapies, antibodies, oligonucleotides and small-molecule therapeutics.
  • Demonstrate and maintain comprehensive cross-functional and industry perspective, judgement and ability to apply understanding to individual projects and programs.
  • Vision and ability to build and lead a multidisciplinary scientific team in establishing and executing optimal pre/nonclinical development strategy to deliver on RaNA’s strategic Research and Development and portfolio objectives.
  • Effective integration of activities of Translational Development functions (Pharmacology, Pharmacokinetics and Drug Metabolism, Toxicology, Bioanalysis and Biomarkers) with other key functions within RaNA (e.g. Discovery, Chemistry, Clinical, Regulatory).
  • Ability to effectively represent the Company to key external stakeholders and effectively engage and present to staff at all levels, including senior management, alliance partners and global regulatory agencies, clearly and at the appropriate level of detail in representing Translational strategy, results and findings.
  • Ability to rapidly assimilate/synthesize data and information from diverse sources, make judgments on complex/abstract problems and develop innovative solutions as necessary.
  • Demonstrated ability in problem solving as applied to drug development and program/functional management, including crisp decision-making following appropriate consultation, even in times of ambiguity.
  • Excellent interpersonal skills including active listening, effective meeting management, negotiation, and optimizing group dynamics. Must be open to the ideas of others and utilize different perspectives to drive towards solutions. Ability to influence through effective communication, respectful challenge, and persuasion across the Research and development organization is essential.
  • Develop and implement translational and early development strategies optimized for therapeutic modality, disease indication, clinical and regulatory development pathways, including development and execution of strategy for quantitative analysis of compounds, immunogenicity assessment and identification and implementation of clinically relevant biomarkers during preclinical and clinical development.
  • Ensure that pre/nonclinical data packages are generated to support robust, rapid development candidate selection, and provide ongoing translational support of these candidates into and through clinical development, registration and commercialization.
  • Establish and maintain high quality systems and procedures for outsourcing, managing and reporting for RaNA portfolio programs and to oversee the generation of documentation for the pre/nonclinical components of regulatory submissions. Identifying and introducing new enabling technologies and identification of external capabilities as necessary.
  • Ability to establish, develop and manage relationships with key external knowledge and opinion leaders (KOLs), alliance partners, collaborators and other lop world class scientific experts.
  • Serve as a member of the RaNA Research and Development Leadership Team, influence the operations and future strategy of the division, fostering a culture of openness, creativity and innovation and personify a sense of urgency and can do spirit.

Education and Experience Requirements

  • PhD and/or M.D. in Pharmacology, Pharmacokinetics, Toxicology, Biochemistry or related field
  • 12+ years of experience working within the biotechnology or pharmaceutical industry, including previous work in the preclinical evaluation and development of nucleic acid and small molecule therapeutics. Experience in rare diseases and with oligonucleotide-based therapeutics is preferred.
  • Significant experience leading experienced teams of scientists from multiple disciplines.
  • Demonstrated knowledge of global regulatory requirements and expectations for nonclinical packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
  • Experience representing function to global regulatory agencies in support of submissions at all stages of development, ie, IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA.
  • Extensive experience in the outsourcing and external oversight of GxP compliant translational and pre/nonclinical development studies conducted by qualified suppliers.
  • Evidence of thought/opinion leadership within the industry, such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
  • Must be motivated, creative, energetic, resourceful and adaptable, responding constructively to challenging new ideas, information, situations or criticism.
  • Fluency in written and spoken English is required.
  • Domestic and occasional international travel required.

To apply, please email your CV to careers@ranarx.com.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S. RaNA has a competitive employee benefits package that includes health/dental insurance, 401K retirement plan and company match, paid vacation, and much more!

Head of Toxicology

We are seeking a highly motivated and scientifically rigorous individual to join RaNA and lead our Toxicology efforts.  The successful candidate will report to the Head of Translational Development and will be an integral part of the Research and Development team.

Summary of Role

The Head of Toxicology is responsible for providing strategy, expertise, representation and resources for assessment of drug safety to all program teams and RaNA management across all therapeutic areas and stages of development. S/he will provide leadership and oversight of the Toxicology group, and will work closely with Discovery, Chemistry, Regulatory and Clinical colleagues to assess the safety profiles of optimized leads and early development candidates and determine clinical safe starting dose, dose range, safety margins and anticipated safety parameters to be monitored during clinical development.  In addition, the Toxicology organization will be responsible for design and conduct of all phase-appropriate and registration-enabling studies (eg, DART, safety pharmacology, carcinogenicity). The successful group leader is expected to maintain a flat, consensus-driven team and to balance big picture, long-term and strategic considerations with tactical, detailed technical aspects in approaching and dealing with project/program or product-related drug safety issues. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The Head of Toxicology develops and implements strategic plans for nonclinical drug safety assessment and actively participates in program teams, providing expert representation to global regulatory agencies as well as collaborating with R&D leadership and assisting in the identification of new business initiatives and in-licensing opportunities. The successful candidate will establish and maintain high quality systems and procedures for outsourcing, managing and reporting regulatory toxicology programs, studies and other activities in support of RaNA portfolio programs and to provide submission-ready documentation for the toxicology components of regulatory submissions.

Key Competencies

  • A broad understanding of the drug development process and the ability to provide expert guidance in designing and implementing nonclinical Toxicology and Safety Pharmacology studies and development programs for biopharmaceuticals including protein therapies, antibodies, oligonucleotides and small-molecule therapeutics.
  • Ability to analyze, interpret and document nonclinical Toxicology data with overall responsibility to ensure that sufficient preclinical safety data and knowledge exist to underwrite safe and effective human administration.
  • Experience within a team environment as both a member and a leader with strong organizational and interpersonal skills, including exceptional oral and written communication skills with a demonstrated ability to write protocols, nonclinical/clinical study reports and scientific peer-reviewed publications.
  • Ability to influence through effective communication, respectful challenge, and persuasion across the Research and development organization is essential.
  • Ability to effectively represent the Company to key external stakeholders, effectively engage and present to staff at all levels, including senior management and technical and business experts clearly and at the appropriate level of detail in representing strategy, results and implications.
  • Demonstrate and maintain comprehensive cross-functional and industry perspective, judgement and ability to apply understanding to individual projects and programs.

Education and Experience Requirements

  • PhD in a related subject, with DABT certification.
  • 10+ years industry-related experience in regulatory Toxicology working within the biotechnology or pharmaceutical industry, including previous work with nucleic acid therapeutics.
  • Hands-on experience in all aspects of Toxicology study conduct including general, genetic, developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology and environmental risk assessment experience.
  • Demonstrated knowledge of global regulatory requirements and expectations for nonclinical safety assessment packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
  • Experience authoring relevant sections of regulatory documents and providing expert representation to global regulatory agencies in support of submissions at all stages of development, ie, IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA.
  • Extensive experience in the outsourcing and external oversight of nonclinical Toxicology studies conducted by qualified suppliers.
  • Experience in providing formal scientific/technical due diligence support for Business Development activities is required.
  • Evidence of leadership within the industry, eg such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
  • Must be able to balance big picture thinking with fine detail level analysis and have demonstrated ability in problem solving as applied to drug development and program/functional management.
  • Must be motivated, creative, energetic, resourceful and adaptable, responding constructively to challenge, new ideas, information, situations or criticism.
  • Fluency in written and spoken English is required.
  • Domestic and occasional international travel required.

To apply, please email your CV to careers@ranarx.com.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S. RaNA has a competitive employee benefits package that includes health/dental insurance, 401K retirement plan and company match, paid vacation, and much more!

Head of Pharmacokinetics and Drug Metabolism

We are seeking a highly motivated and scientifically rigorous individual to join RaNA and lead our PKPD efforts.  The successful candidate will report to Head of Translational Development and will be an integral part of the Research and Development team.

Summary of Role

The Head of Pharmacokinetics and Drug Metabolism (PKDM) is responsible for providing PKDM strategy, expertise, representation and resources to all program teams and RaNA management across all therapeutic areas and stages of development.  S/he will provide leadership and oversight of the PKDM group and will work closely with Discovery, Chemistry, Regulatory and Clinical colleagues to generate and integrate PK and ADME data leading to the estimation of safe and efficacious first in human clinical dose and regimen for novel therapeutics, as well as predicted clinical PK and PK/PD profiles and optimal posology. In addition, the PKDM organization will be responsible for design, analysis and reporting for all phase-appropriate and registration-enabling studies (eg, bioavailability, ADME, bioequivalence, DDI, food-effect). The successful group leader is expected to maintain a flat, consensus-driven team and to balance big picture, long-term and strategic considerations with tactical, detailed technical aspects in approaching and dealing with program-related PKDM issues. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The Head of PKDM develops and implements strategic plans for preclinical and clinical pharmacokinetics and actively participates in program teams, providing expert representation to global regulatory agencies as well as collaborating with R&D leadership and assisting in the identification of new business initiatives and in-licensing opportunities. The successful candidate will establish and maintain appropriate quality systems and procedures for outsourcing, managing and reporting for PKDM studies and other activities in support of RaNA portfolio programs, and provide submission-ready documentation for the PKDM components of regulatory submissions.

Key Competencies

  • A broad understanding of the drug development process and the ability to provide expert guidance in designing and implementing nonclinical PKDM studies and development programs for biopharmaceuticals including protein therapies, antibodies, oligonucleotides and small-molecule therapeutics.
  • Demonstrated knowledge of global regulatory requirements and expectations for nonclinical and clinical PKDM packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
  • Ability to analyze, interpret and document nonclinical and clinical pharmacokinetic/ADME and PK/PD data with overall responsibility to ensure that sufficient preclinical PK/ADME and PK/PD knowledge exists to underwrite safe and effective human administration.
  • Experience within a team environment as both a member and a leader with strong organizational and interpersonal skills, including exceptional oral and written communication skills with a demonstrated ability to write protocols, nonclinical/clinical study reports and scientific peer-reviewed publications.
  • Ability to influence through effective communication, respectful challenge, and persuasion across the Research and Development organization is essential.
  • Ability to effectively represent the Company to key external stakeholders, effectively engage and present to staff at all levels, including senior management and technical and business experts clearly and at the appropriate level of detail in representing strategy, results and implications.
  • Demonstrate and maintain comprehensive cross-functional and industry perspective, judgement and ability to apply understanding to individual projects and programs.

Education and Experience Requirements

  • PhD in a related subject.
  • 8-10+ years industry-related experience in regulatory PKDM working within the biotechnology or pharmaceutical industry, including previous work with nucleic acid therapeutics.
  • Extensive training in pharmacokinetic analysis and biostatistics, including construction of PK and PK/PD models, simulation, and prediction of first-in-human and human equivalent doses is required.
  • Hands-on experience in all aspects of PKDM study conduct, including: study design, execution interpretation and reporting, in vitro/in vivo PK & PD and ADME, methods, animal models, inter-species scaling, advanced data analysis, modeling and simulation, reporting and compliance.
  • Experience authoring relevant sections of regulatory documents and providing expert representation to global regulatory agencies in support of submissions at all stages of development, ie, IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA.
  • Extensive experience in the outsourcing and external oversight of PKDM studies conducted by qualified suppliers.
  • Experience in providing formal scientific/technical due diligence support for Business Development activities is required.
  • Evidence of leadership within the industry, eg such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
  • Must be motivated, creative, energetic, resourceful and adaptable, responding constructively to challenge, new ideas, information, situations or criticism.
  • Must be able to balance big picture thinking with fine detail level analysis and have demonstrated ability in problem solving as applied to drug development and program/functional management.
  • Fluency in written and spoken English is required.
  • Domestic and occasional international travel required.

To apply, please email your CV to careers@ranarx.com.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S. RaNA has a competitive employee benefits package that includes health/dental insurance, 401K retirement plan and company match, paid vacation, and much more!

We are currently seeking a highly motivated, rigorous and talented Senior Research Associate or Research Associate to join our Screening and Core Technology group.  The Screening and Core Technology group covers screening, internal next generation screen activities, CRISPR based gene editing efforts, and the growth, maintenance, and differentiation of iPSCs or primary cells in 2D, 3D, and organoid cultures. This position will be primarily responsible for in vitro RT-qPCR based screening to support our new liver target platform. This person will also act as the lab manager for the Biology teams at RaNA and coordinate shipping and stocking through external vendors.  Additional responsibilities may also include support for CRISPR gene editing, cross-training for the Next-Gen screening, development and validation of new gene expression panels, and validation of protein expression and functional analysis. She/he has demonstrated capability to work independently as well as in team setting.

Required Experience, Education and Capabilities

  • BS/MS degree in biology, biochemistry or related area and an understanding of molecular biology and tissue culture techniques.
  • Must have hands-on experience screening compounds in cell based assays, including mammalian cell culture, transfections, and RNA and protein analysis, working with 96 and 384-well formats and multichannel pipettes, and be comfortable working at mid to high throughput
  • Experience with cellular and molecular biology techniques is required, including RNA and protein isolation, qRT-PCR, ELISA, western blotting, RNAi approaches, tissue handling, and in vitro systems.
  • Experience with oligos, HCC cell lines, Cell to Ct RNA isolation reagents, lipid based transfection reagents, and the Viaa7 qPCR machine is desired.
  • Experience with next generation library preparation and sequencing is a plus.
  • Strong data analysis skills are required.
  • Demonstrated ability to troubleshoot technical assays, instruments and protocols.
  • Ability to multitask and work independently and collaboratively as part of an interdisciplinary team in a matrix environment with 15-20 scientists. Excellent organizational and time management skills, the ability to generate high quality data under tight deadlines.
  • Excellent organizational and communication skills to participating in multiple projects in a matrix research organization. He/she should have the ability to present data and share insights with team members on selected project teams and to the communicate the impact of their work to a larger audience, not only within RaNA but to the greater scientific community as well.

We are seeking a highly motivated and scientifically rigorous individual to join our team as a Senior Scientist.  The successful candidate will report to the Senior Director, Manufacturing and be an integral part of the MRT production team. The position will focus on drug substance and drug product manufacture, regulatory and analytical support, including development, validation, and data review for drug substances and drug products.  The position will help develop scalable and robust formulation processes for drug substance and drug product and serve as the process knowledge link between Process Development and drug substance and drug product manufacturing.

Key Skills and Competencies

  • Coordinate technology transfer of mRNA and nanoparticle manufacturing processes.
  • Demonstrated expertise in process development/scale-up of drug product formulation.
  • Design and conduct experiments to investigate the impact of formulation parameters on drug product processes.
  • Identify solutions, including process analytical technologies which lead to robust process control strategies.
  • Ability to provide technical support and resolve scale-up and manufacturing issues, develop solutions to improve process efficiency and product quality.
  • Prepare technical reports and presentations that support scale-up activities and process improvements.
  • Support and contribute to IND filings/regulatory documentation

 Qualifications

  • Chemistry, Chemical engineering or Biochemistry BS/MS with 12+ years of experience or PhD with 6+ years of experience in pharmaceutical or biotechnology company.
  • Demonstrated success in nucleic acid delivery and the development of novel drug carriers with hands-on technology transfer experience in lipid nanoparticle (LNP) and polymer-based nanoparticle formulations.
  • Experience with analytical tools for release and characterization of drug product processes and drug products.
  • Demonstrated ability to apply fundamental scientific and engineering skills to evaluation of processes and development of practical solutions to technical challenges.
  • Strong familiarity with cGMP, ICH and regulatory guidelines
  • Ability to work with CROs/CMOs
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Operational execution and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

 

We are searching for a highly motivated individual to join the RaNA team as a Project Manager. The successful candidate will partner with the Sr. Director of Program Management to prepare critical data for governance presentations, proactively manage timelines, budgets and assist in the analysis of options across the portfolio. He/she will play a role in the continuous optimization of the portfolio and program management function to support organizational growth as assets move from research/development through the clinic, and will also assist with the day to day management of key activities associated with highly functioning project teams, including the identification, tracking and management of critical activities to ensure programs progress as planned. In addition, the project manager will be responsible for creating and managing various project plans, establishing agendas, minutes etc. and working closely with functional leads to ensure accurate, timely project updates that will drive key decisions.

Key Competencies

  • Candidate will have a minimum of 3-5 years direct experience in a biotechnology organization and a proven ability to work cross functionally at all organizational levels.
  • Strong interpersonal skills, self-awareness and ability to manage team dynamics. Displays a high degree of integrity, enthusiasm and operates from a frame work of possibility.
  • Demonstrated success with handling multiple projects coupled with a strong knowledge of the discovery and development process.
  • Must be motivated, creative, energetic and adaptable, responding constructively to challenging new ideas, information and situations.
  • Excellent organization skills with great attention to detail and a desire to grow within a dynamic, fast paced biotechnology organization.
  • Individual is driven by a sense of urgency to develop therapies for patients with significant unmet medical needs.

Requirements

  • BS/MS/PhD in scientific discipline and/or MBA with relevant 3-5 years of biotechnology experience.
  • Fluency in written and spoken English is required.
  • Excellent knowledge with all aspects of MS Office including Visio and MS Project.
  • Domestic and occasional international travel may be required.
  • PMP certification preferred but not required.
  • Only candidates with demonstrated experience as described in the role summary will be considered for this highly visible role.

We are seeking a highly motivated and organized individual to join our team as a Project Manager.   The successful candidate will report to the Sr. Director of Manufacturing and be an integral part of the CMC team.  This position offers opportunities to work with multiple external CROs and CMOs in addition to the RaNA Therapeutics team.  The successful candidate will be responsible for management of multiple external CMC-related projects.

Primary Responsibilities

  • Manage CMC projects outsourced to multiple CROs / CMOs. Collaborate with internal and external teams to set priorities, plan activities, monitor progress, make decisions, resolve issues and identify risks and mitigation plans.
  • Track timelines, milestones and deliverables for outsourced projects to provide input into overarching program plan.
  • Manage inventory of multiple raw materials required for drug substance and drug product production. Coordinate with multiple vendors to order required raw materials and monitor outstanding deliveries.
  • Review and approve project/product related documentation including protocols, reports, procedures and specifications.
  • Assist in compilation of CMC information to support IND applications.
  • Assist in the development of new contracts with external CROs / CMOs. Track invoices against purchase orders.  Assist with budget planning and development.

Qualifications

  • Bachelor’s or Master’s degree in life sciences or engineering.
  • 5-8 years (Bachelor’s) / 3-5 years (Master’s) experience in a similar position, 5-10 total years’ experience in the biotechnology / pharmaceutical industry.
  • Demonstrated success in managing multiple projects effectively.
  • Ability to effectively represent the Company to external CROs and CMOs.
  • Knowledge of product development process including typical Chemistry, Manufacturing and Controls (CMC) activities.
  • Experience with analytical method development and qualification, process development, and cGMP manufacturing and release.
  • Desire to work in a fast-paced environment.
  • Excellent organizational and communication skills.
  • PMP certification desirable.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

We are seeking a highly motivated and scientifically rigorous individual to join our team as an Associate Scientist. The successful candidate will report to the Associate Director/Group Leader and be an integral part of the MRT team.  This position offers opportunities to discover, create and research new mRNA-based drug therapeutics for the treatment of a wide array of genetic diseases.  The successful candidate will be responsible for supporting full characterization of mRNA therapeutic candidates through a wide range of analysis of in vitro and in vivo studies.  Further, development of key assays for biological detection of both mRNA and protein targets, characterization of drug substance material as well as other critical responsibilities will be expected of a successful candidate.

Primary Responsibilities

  • Support all in vitro and in vivo analysis for the detection, characterization, quantification and activity of both mRNA target drug substances as well as specific protein targets.
  • Conduct biological assays such as ELISA, western blot, gel electrophoresis supporting lead programs
  • Maintain multiple cell lines for tissue culture using proper aseptic techniques
  • Perform critical analyses for in vivo studies spanning multiple lead programs
  • Develop & conduct new assays for characterization of target protein
  • Prepare technical reports and makes recommendations based on research outcomes

Qualifications

  • M.S. in Biology or Biochemistry
  • 6-10 years of industrial experience preferred
  • Strong knowledge and execution of assay development (ELISA, enzyme activity, western blot, silver stain, etc.) for protein detection and quantification is imperative for success
  • Extensive experience in maintaining multiple cell lines simultaneously under minimal supervision is required
  • Ability to design, conduct and analyze transfection-based studies involving nucleic acids
  • Previous work with mRNA (handling/isolation/quantification/characterization) is highly desired and would be considered over other candidates
  • Demonstrated record of successful in vitro/in vivo analysis supporting lead programs including proper tissue handling, homogenization, protein/RNA isolation, etc.
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

We are seeking a highly motivated and scientifically rigorous individual to join our team as an Associate Scientist, mRNA Process Development and Biological Characterization. The successful candidate will report to the Associate Director/Group Leader and be an integral part of the MRT team.  This position offers opportunities to discover, create leading mRNA production processes providing crucial drug substance material applicable for the treatment of a wide array of genetic diseases.  The successful candidate will be responsible for supporting mRNA process development for our MRT platform encompassing the development of the largest scale mRNA production in the industry, optimization of current small scale mRNA batch production, full characterization of drug substance material as well as other critical responsibilities.

Primary Responsibilities

  • Support mRNA process development efforts for multiple mRNA drug targets entailing: large-scale batch production, batch record execution/maintenance, optimization of mRNA processes (enzymatic/physical/analytical)
  • Provide accurate and reproducible execution of analytical characterization for full release panel for mRNA drug substance
  • Conduct biological assays such as ELISA, western blot, gel electrophoresis supporting lead programs
  • Prepare technical reports and makes recommendations based on research outcomes

Qualifications

  • M.S. in Biology, Biochemistry, Engineering
  • 6-10 years of industrial experience preferred
  • Demonstrated success in nucleic acid synthesis/handling(RNase-Free)/application with hands-on experience in messenger RNA production/characterization (required)
  • Further experience with process development/scale-up and a working knowledge of batch record documentation is highly desired
  • Familiarity with GMP operations is preferred
  • Strong disposition for analytics (QC, methods, assay development)
  • Ability to conduct routine biological assays including ELISA, western blot, silver stain, gel electrophoresis, etc. would be preferred
  • Handling/analysis of in vitro/in vivo tissue and serum samples is advantageous
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

We are seeking a highly motivated and scientifically rigorous individual to join our team as a Principal Development Scientist. The successful candidate will report to the Senior Director, Manufacturing and be an integral part of the MRT team. The position will focus on drug substance and drug product manufacture, drug formulation, regulatory and analytical support, including development, validation, and data review for drug substances and drug products.

Will also provide technical support to the MRT team for the pharmaceutical development of RaNA’s Messenger RNA Therapeutics lead candidates.  The position will help develop scalable and robust formulation processes for drug substance and drug product and serve as the process knowledge link between Process Development and drug substance and drug product manufacturing.

Primary Responsibilities

80%

  • Provide technical leadership for drug product development and tech transfer activities.
  • Author/review development documents and support IND regulatory submissions
  • Represent within cross functional project teams including process development, CMC and tech transfer teams
  • Will provide support in laboratory to Process Development team when needed as it relates to manufacture of DS or DP.          
  • Manages and oversees the development of drug substances and drug formulations and/or transfer of development activities with RaNA contractors.
  • Provides technical input for selecting external RaNA contractors as well as managing the day-to-day contractor activities with MRT Program Managers.
  • Leads drug /device compatibility assessment activities.
  • Works closely with GMP manufacturers of drug products and drug substances.
  • Writes/reviews protocols and performs batch record review for manufacturer of drug substances and drug products.
  • Writes/reviews analytical method protocols and stability protocols.
  • Writes CMC and drug/device compatibility documents to support IND filings.
  • Provides any necessary support to line manager as required

20%

  • Assists in the review and evaluation of CMC documents during a due diligence exercise.
  • Uses DOE and QbD principles in developing robust API and Finished Product manufacturing processes

Key Skills and Competencies

  • The principal development scientist position will work closely with groups within MRT including Process and Analytical Development as well as external contract organizations, and participate /lead tech transfer teams and work with CMO on cGMP manufacture and release of drug product.
  • Extensive experience and demonstrated track record in biopharmaceutical development including but not limited to formulation development, drug product development, drug product process characterization and validation.
  • In-depth understanding of nucleic acid drug development, formulation, delivery systems and drug/device characterization.
  • Must be well-organized and self-motivated, and possess an independent work style.
  • Ability to lead effectively and concurrently on multiple projects in a goal-oriented, timeline-driven, and dynamic work environment while ensuring quality and accuracy.
  • Proactively identify potential issues and develop creative solutions to technical problems to keep projects on schedule.
  • Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside RaNA.

Qualifications

  • Ph.D. degree in pharmaceutical chemistry, biochemistry, engineering or related disciplines.
  • Minimum of 8 years of experience in pharmaceutical development and manufacturing of nucleic acid-based therapeutics.
  • Experience with PD/mfg, release testing, formulation development, drug/device characterization

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

We are seeking a highly motivated and scientifically rigorous individual to join our team as a Research Specialist II/Sr. Research Specialist.   The successful candidate will report to the Associate Director/Group Leader and be an integral part of the MRT Drug Delivery team.  This position offers opportunities to discover, formulate and support leading mRNA formulations for the treatment of a wide array of genetic diseases.  The successful candidate will be responsible for supporting key formulation development for our MRT platform encompassing in vitro/in vivo mRNA formulation screening, routine characterization of both drug substance (nucleic acid payload) and drug product as well as other critical responsibilities.

Primary Responsibilities

  • Support laboratory formulation development of mRNA drug targets entailing: production of LNP/polymer-based nanoparticles for in vivo studies, formulation characterization, and assay development
  • Contribute to scale-up activities for large scale production of RNA drug product (support/conduct scaled-up formulation processes to establish successful drug product process development, batch record analysis)
  • Provide formulations and perform characterizational assay support/data analysis for CROs with focus on in vivo studies, drug carrier design/development, assay development
  • Prepare technical reports and makes recommendations based on research outcomes

Qualifications

  • B.S/M.S in Chemistry, Chemical engineering or Biochemistry
  • 4-6 years (B.S.) or 2-4 years (M.S.) of industrial experience preferred
  • Demonstrated success in nucleic acid delivery with hands-on experience in lipid nanoparticle (LNP) formulations, polymer-based nanoparticles & characterization (required)
  • Direct experience with messenger RNA encapsulation/characterization/handling is preferred
  • Further experience with process development/scale-up and familiarity with batch record documentation is highly desired
  • Proficiency in analytical techniques (HPLC/UPLC, DLS, CD, zeta potential, UV-Vis and fluorescence spectrophotometry)
  • Demonstrated understanding and success in implementation of RNA-related analytics (Ribogreen, gel electrophoresis, capillary electrophoresis, etc.)
  • Experience in developing lyophilized formulations is a plus
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

We are seeking a highly motivated and scientifically rigorous individual to join our team as a Scientist.   The successful candidate will report to the Associate Director/Group Leader and be an integral part of the MRT Drug Delivery team.  This position offers opportunities to discover, formulate and create leading mRNA formulations for the treatment of a wide array of genetic diseases.  The successful candidate will be responsible for supporting key formulation development for our MRT platform encompassing in vitro/in vivo mRNA formulation screening, nanoparticle design and characterization, new delivery modalities and applications as well as other critical responsibilities.

Primary Responsibilities

  • Lead laboratory formulation development of mRNA drug targets entailing: production of LNP/polymer-based nanoparticles for in vivo studies, formulation optimization and characterization
  • Support scale-up activities for large scale production of RNA/carrier drug product (design, execution, batch record production/analysis)
  • Manage outside relationships with CROs with focus on in vivo studies, drug carrier design/development, assay development
  • Develop alternate formulations tailored for various routes of administration
  • Prepare technical reports, presentations, etc. for clear communication of scientific findings to cross-functional groups

Qualifications

  • Ph.D. in Chemistry, Chemical engineering or Biochemistry
  • 1-3 years of industrial experience preferred
  • Demonstrated success in nucleic acid delivery and the development of novel drug carriers with hands-on experience in lipid nanoparticle (LNP) formulations, polymer-based nanoparticles & characterization (required)
  • Direct experience with messenger RNA encapsulation/characterization/handling is preferred
  • Further experience with process development/scale-up is highly desired
  • Working knowledge of organic chemistry and its applications to drug delivery (required)
  • Previous experience designing successful drug products for various routes of administration (subcutaneous, intramuscular, pulmonary, CNS, etc.)
  • Familiarity with lyophilization theory and techniques
  • Strong disposition for analytics (QC, methods, assay development)
  • Demonstrated experience in working with outside CROs/CMOs
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

 

 

 

 

 

We are seeking a highly motivated and scientifically rigorous individual to join our team as Associate Director, Regulatory Operations. The successful candidate will report to the Chief Scientific Officer and be an integral part of the R&D team. This position offers opportunities to develop and execute the global regulatory strategy for a portfolio of mRNA-based therapies. The successful candidate will be responsible for developing and directing global regulatory strategy; planning, overseeing and delivering all regulatory filings; and managing all interactions and meetings with regulatory agencies.

Primary Responsibilities

  • Develop and direct the global regulatory strategy and objectives for multiple mRNA-based therapeutics. As the regulatory lead, represent regulatory on all key internal decision-making teams and on all external interactions with regulatory agencies.
  • Based on technical and regulatory knowledge, provide proactive guidance to internal teams on the development of strategic plans, specifically to identify and assess regulatory risks associated with different strategies; and help internal teams problem-solve complex regulatory and clinical issues, and generate options for decision-making.
  • Lead the development and submission of regulatory documents, e.g., pre-IND and end-of-Phase 2 briefing books, INDs, NDA/BLAs, CTAs, MAAs, and other relevant regulatory filings (responses to regulatory queries, IND safety reports).
  • Lead and facilitate meetings with regulatory agencies and prepare internal teams for these interactions.
  • Clearly communicate the regulatory strategy and deliverables to project teams, and proactively drive project teams and external vendors to meet the designated timelines for deliverables.

Qualifications

  • BA, BS, MA, MS, PhD, MD in science or healthcare preferred, or equivalent relevant experience.
  • At least 8-10 years of regulatory affairs or equivalent experience. The regulatory experience should be sufficiently broad to ensure appropriate regulatory leadership for all stages of development.
  • Demonstrated success in guiding the development of new investigational products, spanning preclinical through Phase 3 clinical development.
  • Hands-on experience in the preparation of regulatory filings, including preparation of INDs and NDAs/BLAs, and pre-IND and end-of-Phase 2 meeting materials.
  • Experience with FDA and EMA interactions, and interactions with other global regulatory agencies highly preferred. Experience in conducting face-to-face and teleconference meetings with regulatory agencies.
  • Strong competency in understanding global regulatory requirements and emerging changes in the global regulatory landscape.
  • Strong analytical and problem-solving skills; specifically, to analyze and interpret scientific and clinical data, and to problem-solve complex regulatory and clinical issues.
  • Ability to present complex issues in oral and written form.
  • Excellent organizational skills.
  • Desire to work in a fast-paced environment.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

We are seeking highly motivated and team-oriented Senior Administrative Assistant to join RaNA.  The Senior Administrative Assistant will provide support to the R&D leadership team. Daily activities require thorough knowledge of company operations, policies and procedures.  This role involves handling details of a highly confidential and critical nature, and collecting and preparing information for use in discussions/meetings of executive staff including Strategic Advisory Board and Board of Directors, as well as outside individuals. Must be a detail-oriented self-starter with the ability to manage multiple projects simultaneously. Must have excellent interpersonal skills to work effectively with all levels of the organization and high-level external contacts.

Key Responsibilities

  • Calendar management: Manage calendars of R&D leadership with keen attention to detail, schedule meetings and interviews, arrange travel and oversee related logistics, and manage expense reporting process.
  • Meeting planning: Responsible for department meeting planning and organization (schedule attendees, set up conference line for remote attendees, book conference rooms, arrange catering, prepare presentations, meeting materials, book travel for external guests, etc). This includes weekly research meetings, Scientific Advisory Board meetings, and other R&D-focused meetings.
  • Document organization: Responsible for developing and maintaining filing systems, both hard copies (as appropriate) and electronic copies on the corporate file share with guidance from R&D leadership. Serve as the first point of contact for new/renewed contracts, maintaining an index of ongoing contracts/expiring contracts, in support of the General Counsel. Manage the shipping permit process in collaboration with the Director of Facilities.
  • Lab supply ordering: Responsible for managing ongoing/recurring bulk lab orders, working closely with the R&D organization to understand ongoing needs and forecast future orders.
  • Scientific publication library maintenance: Maintain RaNA’s scientific publication library and purchases. Assist in the distribution of relevant materials as needed, and handle incoming requests from the R&D team for archived documents.
  • Additional R&D support: As needed, support R&D management in preparing and editing presentations. Proactively respond to questions, concerns, and requests for information and resolve routine questions and information requests.
  • Administrative support: As needed, serve as back-up support to the office manager and executive assistant. This may include covering the front desk, greeting guests, and directing calls accordingly to ensure smooth day-to-day operations.

Requirements

  • Bachelor’s degree
  • 5+ years administrative experience; Pharmaceutical industry experience highly preferred
  • Highly proficient in Microsoft Office packages including MS Outlook, Word, Excel, PowerPoint
  • Excellent oral and written communication, time management and organization skills
  • Travel/meetings management experience
  • Ability to handle highly confidential information with discretion
  • Experience supporting more than one person preferred

 

 

We are seeking a highly motivated and scientifically rigorous individual to join our team as Clinical Program Lead. The successful candidate will report to the Vice President of MRT Clinical Operations and be an integral part of the MRT team. This position offers the opportunity to have a primary role in the clinical development of a portfolio of mRNA-based therapies. The successful candidate will be responsible for the strategic and operational oversight, management, and delivery of all clinical studies in the program.

Primary Responsibilities

  • Responsible for the strategic and operational aspects of the clinical studies in the development program for multiple mRNA-based therapeutics. As the Clinical Program Lead, provides functional input into the clinical development plan that is consistent with the goals of the program.
  • Authors, provides input, and/or oversees program and/or study documents.
  • Manages clinical outsourcing and is the representative on CRO and other vendor oversight teams.
  • Manages financial aspects of studies, including CRO and investigator budgets. Provides critical review of contracts and/or work orders, and oversees ongoing performance of CROs and other vendors.
  • Collaborates with project physician, data manager and statistician, and other relevant functional areas on clinical trial design and CRF generation.
  • Oversees study level document generation (e.g., clinical study reports, ICFs, trial submissions to regulatory agencies, pharmacy and lab manuals).
  • Participates in the selection of investigational sites with project physician.
  • Ensures clinical trial site’s adherence to pertinent regulations. Leads ongoing review of data to ensure GCP.
  • Clearly communicate the clinical development strategy and deliverables to project teams and external vendors, and proactively drive project teams and external vendors to meet the designated timelines for deliverables.

Qualifications

  • Bachelor’s degree or nursing qualification is required. Scientific/healthcare field preferred but not required. Advanced degree preferred.
  • Significant clinical research experience (at least 8 years) with evidence of increasing responsibility in a pharmaceutical company or CRO. Clear and thorough understanding of all aspects of clinical trial conduct. Global clinical trial experience is required.
  • Detailed knowledge of current regulatory requirements and guidelines governing clinical research.
  • Participation in IND and NDA/BLA submissions is preferred.
  • Experience leading cross-functional teams.
  • Excellent communication and organizational skills.
  • Desire to work in a fast-paced environment.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.

We are seeking highly motivated and scientifically rigorous individual at the Sr. Scientist level to join the RaNA.  The successful candidate will report to the Head of Chemistry and be an integral part of the team.

Responsibilities:

  • Develop oligonucleotide delivery strategies to expand the opportunities to extrahepatic tissues
  • Independently search existing literature and build a strong knowledge of the RNA therapeutics delivery field
  • Optimize and develop effective targeted ligand oligonucleotide conjugation chemistries
  • Demonstrate creativity by identifying new chemical entities as a part of developing novel delivery strategies
  • Exhibit attention to detail in generating and analyzing high quality data
  • Demonstrate high proficiency in technical and operational aspects of mass spectrometry and HPLC, FPLC, NMR, UV/Vis spectroscopy
  • Identify and build relationships with external collaborators to explore new and novel delivery modalities
  • Work closely and effectively with supervisor to make critical decisions

Requirements:

  • Ph.D. in chemistry, organic chemistry or pharmaceutical science
  • 6+ years of industry experience following post-doc
  • 2-3 years of industrial experience in drug delivery systems, preferably oligonucleotides
  • Experience in conjugation chemistry is a plus
  • Highly skilled in structure elucidation of small molecules including nucleosides, lipids and carbohydrates
  • Hands-on experience in mass spectrometry and HPLC, FPLC, NMR, UV/Vis spectroscopy
  • Excellent written and verbal communication skills to interact within the organization and external collaborators
  • Must be able to work in a fast-paced environment, prioritize, and multitask
  • Must demonstrate the ability to meet aggressive timelines
  • Highly motivated, enthusiastic and able to work independently

To apply, please email your CV to careers@ranarx.com.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S. RaNA has a competitive employee benefits package that includes health/dental insurance, 401K retirement plan and company match, paid vacation, and much more!

 

RaNA Therapeutics is seeking a Head of Intellectual Property to play a key role in our growing organization. The Head of IP will assume primary responsibility for management and strategy of in-house intellectual property matters. In this role, you will work closely with RaNA’s senior leadership, scientists and outside IP counsel to develop RaNA’s intellectual property strategy. The ideal candidate will be action-oriented, possess excellent collaboration and communications skills, and will thrive in an interactive, dynamic, team-oriented culture.

The Head of IP must have the ability to work cross-functionally with internal stake holders and external collaborators to lead and manage a variety of responsibilities. The successful candidate will review and draft patent applications for ideas and inventions arising from RaNA scientific staff, manage RaNA’s outside IP counsel, represent RaNA’s IP interests in third party collaborations or license agreements and provide strategic counsel on freedom to operate.

Primary Responsibilities

  • Provide strategic direction to outside counsel on patent filing and prosecution matters on a global basis
  • Provide patentability and FTO opinions in support of R&D project teams; assist with IP related due diligence, review and agreement negotiation to support investment, partnering and in-licensing activities
  • Identify patentable inventions through frequent interactions with R&D project teams, create appropriate patent protection strategies and execute on those strategies
  • Coordinate and perform FTO and patentability searches to ensure FTO for RaNA’s products and technology
  • Manage the intellectual property and relationships for RaNA’s academic licensors and collaborators
  • Ensure RaNA’s compliance with its academic licenses, including diligence reporting
  • Track and analyze the relevant patent literature from various companies and academic institutions that may be competitors of RaNA
  • Assist or lead, as appropriate, the negotiation and drafting of agreements with IP implications
  • Develop and present materials on relevant laws and legal/business issues

Minimum and Preferred Qualifications

  • J.D. from an accredited U.S. law school and licensed to practice law in Massachusetts
  • Degree in biology, chemistry or life sciences; advanced degree preferred
  • 5+ years of experience with patent drafting, strategy and prosecution with life science companies
  • Experience in both law firm and in-house settings (life sciences company)
  • Experience with biologics IP highly preferred
  • Experience negotiating partnership agreements preferred
  • Transactional experience in drafting and negotiating a wide range of agreements including patent licenses, confidentiality agreements, material transfer agreements and sponsored research agreements preferred
  • Excellent judgment; ability to assess risks and benefits and convey them in a clear and concise manner

 

We are seeking a highly motivated and scientifically rigorous individual to join RaNA and lead our Pharmacology efforts.  The successful candidate will report to Head of Translational Development and will be an integral part of the Research and Development team.

Summary of Role

The Head of Pharmacology is responsible for providing pharmacology strategy, expertise, representation and resources to all program teams and RaNA management across all therapeutic areas and stages of development.  S/he will provide leadership and oversight of the Pharmacology group and will work closely with Discovery, Chemistry, Regulatory and Clinical colleagues to generate and  integrate in vitro and in vivo pharmacology and pharmacogenomic data leading to the demonstration and confirmation of pharmacologic target engagement, mechanism of action (MoA) and proof of concept (PoC) efficacy or pharmacodynamic effect for novel therapeutics in translationally relevant disease models.  In addition, the pharmacology organization will be responsible for exploration and validation of biomarker strategy, identification and validation, as well as study design, analysis and reporting for all phase-appropriate and registration-enabling studies. The successful group leader is expected to maintain a flat, consensus-driven team and to balance big picture, long-term and strategic considerations with tactical, detailed technical aspects in approaching and dealing with program-related pharmacology issues. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The Head of Pharmacology develops and implements strategic plans for preclinical Pharmacology and actively participates in program teams, providing expert representation to global regulatory agencies as well as collaborating with R&D leadership and assisting in the identification of new business initiatives and in-licensing opportunities. The successful candidate will establish and maintain appropriate quality systems and procedures for outsourcing, managing and reporting for Pharmacology studies and other activities in support of RaNA portfolio programs, and provide submission-ready documentation for the Pharmacology components of regulatory submissions.

Key Competencies

  • A broad understanding of the drug development process and the ability to provide expert guidance in designing and implementing nonclinical Pharmacology studies and development programs for biopharmaceuticals including protein therapies, antibodies, oligonucleotides and small-molecule therapeutics.
  • Demonstrated knowledge of global regulatory requirements and expectations for nonclinical Pharmacology packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
  • Ability to analyze, interpret and document nonclinical Pharmacology and PK/PD data with overall responsibility to ensure that sufficient preclinical knowledge exists to validate the mechanism of action (MoA) for clinical and regulatory purposes prior to human administration.
  • Experience within a team environment as both a member and a leader with strong organizational and interpersonal skills, including exceptional oral and written communication skills with a demonstrated ability to write protocols, nonclinical/clinical study reports and scientific peer-reviewed publications.
  • Ability to influence through effective communication, respectful challenge, and persuasion across the Research and Development organization is essential.
  • Ability to effectively represent the Company to key external stakeholders, effectively engage and present to staff at all levels, including senior management and technical and business experts clearly and at the appropriate level of detail in representing strategy, results and implications.
  • Demonstrate and maintain comprehensive cross-functional and industry perspective, judgement and ability to apply understanding to individual projects and programs. 

Requirements

  • PhD in a related subject, preferably Pharmacology.
  • 8-10+ years industry-related experience in Pharmacology working within the biotechnology or pharmaceutical industry, including previous work with nucleic acid therapeutics.
  • Extensive training in pharmacokinetic analysis and biostatistics, including development and validation of disease models (eg, liver/metabolic, kidney, ocular, inflammation/immunology, neuromuscular, genetic disease).
  • Hands-on experience in all aspects of Pharmacology study conduct, including: study design, execution interpretation and reporting, in vitro/in vivo, methods, animal models, advanced data analysis, modeling/simulation, reporting and compliance.
  • Experience authoring relevant sections of regulatory documents and providing expert representation to global regulatory agencies in support of submissions at all stages of development, ie, IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA.
  • Extensive experience in the outsourcing and external oversight of Pharmacology studies conducted by qualified suppliers.
  • Experience in providing formal scientific/technical due diligence support for Business Development activities is required.
  • Evidence of leadership within the industry, eg such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
  • Must be motivated, creative, energetic, resourceful and adaptable, responding constructively to challenge, new ideas, information, situations or criticism.
  • Must be able to balance big picture thinking with fine detail level analysis and have demonstrated ability in problem solving as applied to drug development and program/functional management.
  • Fluency in written and spoken English is required.
  • Domestic and occasional international travel required.

 

 

 

We are seeking a highly motivated and scientifically rigorous individual to join RaNA and lead our Translation Development efforts.  The successful candidate will report to the Chief Scientific Officer and be an integral part of the Research and Development Leadership team.

Summary of Role

 The Head of Translational Development will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. S/he must be capable of representing the Company externally in all technical matters, collaborating with other R&D leadership and external alliance partners or collaborators and assisting in the identification of new business initiatives and in-licensing opportunities. The successful candidate will be responsible for design and implementation of Translational Development strategy, providing support and guidance to early preclinical and clinical programs through registration and commercialization.  In addition, s/he will effectively lead and manage the Translational Development department, comprised of Pharmacology, Pharmacokinetics and Drug Metabolism, Toxicology, Bioanalysis and Biomarkers, ensuring that resources are applied appropriately, that Translational Development functions have the leadership, experience and expertise needed to deliver on their goals and that the internal versus external resource balance is maximized. The Head of Translational Development will also establish and develop a broad network of external collaborators in order to maintain cutting edge core competencies, facilitate a proactive outsourcing strategy, and identify novel preclinical development strategies and approaches and to keep abreast of the regulatory environment.

Key Competencies

  • A broad understanding of the drug development process (both large & small molecule) and the ability to provide expert guidance in designing and implementing comprehensive translational development programs for biopharmaceuticals including protein therapies, antibodies, oligonucleotides and small-molecule therapeutics.
  • Demonstrate and maintain comprehensive cross-functional and industry perspective, judgement and ability to apply understanding to individual projects and programs.
  • Vision and ability to build and lead a multidisciplinary scientific team in establishing and executing optimal pre/nonclinical development strategy to deliver on RaNA’s strategic Research and Development and portfolio objectives.
  • Effective integration of activities of Translational Development functions (Pharmacology, Pharmacokinetics and Drug Metabolism, Toxicology, Bioanalysis and Biomarkers) with other key functions within RaNA (e.g. Discovery, Chemistry, Clinical, Regulatory).
  • Ability to effectively represent the Company to key external stakeholders and effectively engage and present to staff at all levels, including senior management, alliance partners and global regulatory agencies, clearly and at the appropriate level of detail in representing Translational strategy, results and findings.
  • Ability to rapidly assimilate/synthesize data and information from diverse sources, make judgments on complex/abstract problems and develop innovative solutions as necessary.
  • Demonstrated ability in problem solving as applied to drug development and program/functional management, including crisp decision-making following appropriate consultation, even in times of ambiguity.
  • Excellent interpersonal skills including active listening, effective meeting management, negotiation, and optimizing group dynamics. Must be open to the ideas of others and utilize different perspectives to drive towards solutions. Ability to influence through effective communication, respectful challenge, and persuasion across the Research and development organization is essential.
  • Develop and implement translational and early development strategies optimized for therapeutic modality, disease indication, clinical and regulatory development pathways, including development and execution of strategy for quantitative analysis of compounds, immunogenicity assessment and identification and implementation of clinically relevant biomarkers during preclinical and clinical development.
  • Ensure that pre/nonclinical data packages are generated to support robust, rapid development candidate selection, and provide ongoing translational support of these candidates into and through clinical development, registration and commercialization.
  • Establish and maintain high quality systems and procedures for outsourcing, managing and reporting for RaNA portfolio programs and to oversee the generation of documentation for the pre/nonclinical components of regulatory submissions. Identifying and introducing new enabling technologies and identification of external capabilities as necessary.
  • Ability to establish, develop and manage relationships with key external knowledge and opinion leaders (KOLs), alliance partners, collaborators and other lop world class scientific experts.
  • Serve as a member of the RaNA Research and Development Leadership Team, influence the operations and future strategy of the division, fostering a culture of openness, creativity and innovation and personify a sense of urgency and can do spirit.

Education and Experience Requirements

  • PhD and/or M.D. in Pharmacology, Pharmacokinetics, Toxicology, Biochemistry or related field
  • 12+ years of experience working within the biotechnology or pharmaceutical industry, including previous work in the preclinical evaluation and development of nucleic acid and small molecule therapeutics. Experience in rare diseases and with oligonucleotide-based therapeutics is preferred.
  • Significant experience leading experienced teams of scientists from multiple disciplines.
  • Demonstrated knowledge of global regulatory requirements and expectations for nonclinical packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
  • Experience representing function to global regulatory agencies in support of submissions at all stages of development, ie, IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA.
  • Extensive experience in the outsourcing and external oversight of GxP compliant translational and pre/nonclinical development studies conducted by qualified suppliers.
  • Evidence of thought/opinion leadership within the industry, such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
  • Must be motivated, creative, energetic, resourceful and adaptable, responding constructively to challenging new ideas, information, situations or criticism.
  • Fluency in written and spoken English is required.
  • Domestic and occasional international travel required.

To apply, please email your CV to careers@ranarx.com.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S. RaNA has a competitive employee benefits package that includes health/dental insurance, 401K retirement plan and company match, paid vacation, and much more!

We are seeking a highly motivated and scientifically rigorous individual to join RaNA and lead our Toxicology efforts.  The successful candidate will report to the Head of Translational Development and will be an integral part of the Research and Development team.

Summary of Role

The Head of Toxicology is responsible for providing strategy, expertise, representation and resources for assessment of drug safety to all program teams and RaNA management across all therapeutic areas and stages of development. S/he will provide leadership and oversight of the Toxicology group, and will work closely with Discovery, Chemistry, Regulatory and Clinical colleagues to assess the safety profiles of optimized leads and early development candidates and determine clinical safe starting dose, dose range, safety margins and anticipated safety parameters to be monitored during clinical development.  In addition, the Toxicology organization will be responsible for design and conduct of all phase-appropriate and registration-enabling studies (eg, DART, safety pharmacology, carcinogenicity). The successful group leader is expected to maintain a flat, consensus-driven team and to balance big picture, long-term and strategic considerations with tactical, detailed technical aspects in approaching and dealing with project/program or product-related drug safety issues. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The Head of Toxicology develops and implements strategic plans for nonclinical drug safety assessment and actively participates in program teams, providing expert representation to global regulatory agencies as well as collaborating with R&D leadership and assisting in the identification of new business initiatives and in-licensing opportunities. The successful candidate will establish and maintain high quality systems and procedures for outsourcing, managing and reporting regulatory toxicology programs, studies and other activities in support of RaNA portfolio programs and to provide submission-ready documentation for the toxicology components of regulatory submissions.

Key Competencies

  • A broad understanding of the drug development process and the ability to provide expert guidance in designing and implementing nonclinical Toxicology and Safety Pharmacology studies and development programs for biopharmaceuticals including protein therapies, antibodies, oligonucleotides and small-molecule therapeutics.
  • Ability to analyze, interpret and document nonclinical Toxicology data with overall responsibility to ensure that sufficient preclinical safety data and knowledge exist to underwrite safe and effective human administration.
  • Experience within a team environment as both a member and a leader with strong organizational and interpersonal skills, including exceptional oral and written communication skills with a demonstrated ability to write protocols, nonclinical/clinical study reports and scientific peer-reviewed publications.
  • Ability to influence through effective communication, respectful challenge, and persuasion across the Research and development organization is essential.
  • Ability to effectively represent the Company to key external stakeholders, effectively engage and present to staff at all levels, including senior management and technical and business experts clearly and at the appropriate level of detail in representing strategy, results and implications.
  • Demonstrate and maintain comprehensive cross-functional and industry perspective, judgement and ability to apply understanding to individual projects and programs.

Education and Experience Requirements

  • PhD in a related subject, with DABT certification.
  • 10+ years industry-related experience in regulatory Toxicology working within the biotechnology or pharmaceutical industry, including previous work with nucleic acid therapeutics.
  • Hands-on experience in all aspects of Toxicology study conduct including general, genetic, developmental and reproductive toxicology, carcinogenicity, toxicokinetics, and safety pharmacology and environmental risk assessment experience.
  • Demonstrated knowledge of global regulatory requirements and expectations for nonclinical safety assessment packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
  • Experience authoring relevant sections of regulatory documents and providing expert representation to global regulatory agencies in support of submissions at all stages of development, ie, IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA.
  • Extensive experience in the outsourcing and external oversight of nonclinical Toxicology studies conducted by qualified suppliers.
  • Experience in providing formal scientific/technical due diligence support for Business Development activities is required.
  • Evidence of leadership within the industry, eg such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
  • Must be able to balance big picture thinking with fine detail level analysis and have demonstrated ability in problem solving as applied to drug development and program/functional management.
  • Must be motivated, creative, energetic, resourceful and adaptable, responding constructively to challenge, new ideas, information, situations or criticism.
  • Fluency in written and spoken English is required.
  • Domestic and occasional international travel required.

To apply, please email your CV to careers@ranarx.com.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S. RaNA has a competitive employee benefits package that includes health/dental insurance, 401K retirement plan and company match, paid vacation, and much more!

We are seeking a highly motivated and scientifically rigorous individual to join RaNA and lead our PKPD efforts.  The successful candidate will report to Head of Translational Development and will be an integral part of the Research and Development team.

Summary of Role

The Head of Pharmacokinetics and Drug Metabolism (PKDM) is responsible for providing PKDM strategy, expertise, representation and resources to all program teams and RaNA management across all therapeutic areas and stages of development.  S/he will provide leadership and oversight of the PKDM group and will work closely with Discovery, Chemistry, Regulatory and Clinical colleagues to generate and integrate PK and ADME data leading to the estimation of safe and efficacious first in human clinical dose and regimen for novel therapeutics, as well as predicted clinical PK and PK/PD profiles and optimal posology. In addition, the PKDM organization will be responsible for design, analysis and reporting for all phase-appropriate and registration-enabling studies (eg, bioavailability, ADME, bioequivalence, DDI, food-effect). The successful group leader is expected to maintain a flat, consensus-driven team and to balance big picture, long-term and strategic considerations with tactical, detailed technical aspects in approaching and dealing with program-related PKDM issues. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The Head of PKDM develops and implements strategic plans for preclinical and clinical pharmacokinetics and actively participates in program teams, providing expert representation to global regulatory agencies as well as collaborating with R&D leadership and assisting in the identification of new business initiatives and in-licensing opportunities. The successful candidate will establish and maintain appropriate quality systems and procedures for outsourcing, managing and reporting for PKDM studies and other activities in support of RaNA portfolio programs, and provide submission-ready documentation for the PKDM components of regulatory submissions.

Key Competencies

  • A broad understanding of the drug development process and the ability to provide expert guidance in designing and implementing nonclinical PKDM studies and development programs for biopharmaceuticals including protein therapies, antibodies, oligonucleotides and small-molecule therapeutics.
  • Demonstrated knowledge of global regulatory requirements and expectations for nonclinical and clinical PKDM packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
  • Ability to analyze, interpret and document nonclinical and clinical pharmacokinetic/ADME and PK/PD data with overall responsibility to ensure that sufficient preclinical PK/ADME and PK/PD knowledge exists to underwrite safe and effective human administration.
  • Experience within a team environment as both a member and a leader with strong organizational and interpersonal skills, including exceptional oral and written communication skills with a demonstrated ability to write protocols, nonclinical/clinical study reports and scientific peer-reviewed publications.
  • Ability to influence through effective communication, respectful challenge, and persuasion across the Research and Development organization is essential.
  • Ability to effectively represent the Company to key external stakeholders, effectively engage and present to staff at all levels, including senior management and technical and business experts clearly and at the appropriate level of detail in representing strategy, results and implications.
  • Demonstrate and maintain comprehensive cross-functional and industry perspective, judgement and ability to apply understanding to individual projects and programs.

Education and Experience Requirements

  • PhD in a related subject.
  • 8-10+ years industry-related experience in regulatory PKDM working within the biotechnology or pharmaceutical industry, including previous work with nucleic acid therapeutics.
  • Extensive training in pharmacokinetic analysis and biostatistics, including construction of PK and PK/PD models, simulation, and prediction of first-in-human and human equivalent doses is required.
  • Hands-on experience in all aspects of PKDM study conduct, including: study design, execution interpretation and reporting, in vitro/in vivo PK & PD and ADME, methods, animal models, inter-species scaling, advanced data analysis, modeling and simulation, reporting and compliance.
  • Experience authoring relevant sections of regulatory documents and providing expert representation to global regulatory agencies in support of submissions at all stages of development, ie, IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA.
  • Extensive experience in the outsourcing and external oversight of PKDM studies conducted by qualified suppliers.
  • Experience in providing formal scientific/technical due diligence support for Business Development activities is required.
  • Evidence of leadership within the industry, eg such as through peer-reviewed publications or as a participant on expert panels or working groups, is preferred.
  • Must be motivated, creative, energetic, resourceful and adaptable, responding constructively to challenge, new ideas, information, situations or criticism.
  • Must be able to balance big picture thinking with fine detail level analysis and have demonstrated ability in problem solving as applied to drug development and program/functional management.
  • Fluency in written and spoken English is required.
  • Domestic and occasional international travel required.

To apply, please email your CV to careers@ranarx.com.

RaNA Therapeutics is committed to equal employment opportunity. All applicants must have authorization to work in the U.S. RaNA has a competitive employee benefits package that includes health/dental insurance, 401K retirement plan and company match, paid vacation, and much more!