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-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

Quote-Brian (1)

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

- Brian Schwartz, Scientist

“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

“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-John

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.

Systems Engineer

RaNA Therapeutics is a growing biopharmaceutical company with sites in Cambridge, MA and Lexington, MA. We are seeking a motivated and customer service oriented Systems Engineer to join our small IT team. The successful candidate will report to the IT Manager and will play an integral role in the ongoing management of and build out of RaNA’s IT capabilities. This position is well suited to an individual that has a strong technical foundation, the ability to work autonomously, and aspirations to broaden their skill set while working in an extremely fast-paced environment where priorities will often shift. If you are seeking a role where you will have the opportunity join an IT team on the ground floor, we’d like to talk to you!

Primary Responsibilities                                     

  • Perform system configurations, software installations, updates, and upgrades to Windows servers and other infrastructure systems
  • Create GXP supporting documentation
  • Provide daily operational support and troubleshooting for Windows server and infrastructure applications
  • Monitor system performance/availability and take appropriate proactive steps to maximize uptime
  • Monitor system security and take appropriate steps to resolve security breaches and prevent future attacks
  • Perform backup operations for organization by supporting current backup environment
  • Work with various IT teams to develop hardware and software specifications for new and upgraded systems
  • Designs, installs, configures, maintains and performs system integration testing of PC/server operating systems
  • Supports web access and electronic messaging systems, and maintains a secure system environments
  • Perform system backups and recovery and monitor system configuration to ensure data integrity and confidentiality
  • Keep current on emerging technologies and standards
  • Provide backup support for centralized administration & operations
  • Provide after-hours on-call support
  • Ensures that all systems and infrastructure applications comply with HIPAA security and privacy rules
  • Perform other duties as assigned

Qualifications

  • Bachelor’s Degree in a technical discipline (Computer Science, MIS, or similar) is preferred
  • 3 to 5 years of proven experience (including at least 2 in the life sciences, biotechnology, or pharmaceutical industry) administering Microsoft Windows operating system and infrastructure applications to include: Windows 2003/2016, IIS 5.0/6.0/7.0; Exchange 365/2016; Oracle 11gr2 -12 c1
  • Strong working knowledge of Active Directory, Group Policy, and other key Microsoft administration concepts to include: Microsoft Terminal Services, Azure, office 365, MDM, Cloud Backup (e.g. Iron Mountain).
  • Experience with Dell, servers and/or Lenovo hardware to include Servers; SAN/NAS storage Exablox; RAID; PCs and Laptops.
  • Experience with virtualization technologies like: VMWare, and/or Xen OS.
  • Demonstrated working knowledge of Networking concepts: DNS, DHCP, SMTP, SNMP, TCP/IP. Scripting technologies: Perl, PowerShell, VBScript, and Windows Batch o Security technologies: host-based security; SFTP, SSH; TrendMicro  Anti-virus, Malware Spyware removal tools, bit locker or PGP Encryption.
  • Experience designing and creating specification documents for servers
  • Experience with creating GXP documentation IQ/OQ/PQ etc.
  • Experience administering system disaster recovery plans including testing and execution with procedure documentation
  • Experience gathering requirements
  • Certificate/License: MCSE or MCSA preferred, or CCNA but not required

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

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.  This experienced professional will provide support to the R&D leadership team. 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 Scientific 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. Daily activities will require thorough knowledge of company operations, policies and procedures.

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, including executive support
  • Pharmaceutical or biotech industry experience is preferred
  • Highly proficient in MS Outlook, Word, Excel, PowerPoint
  • Excellent oral and written communication, time management and organization skills
  • Prior experience managing complex calendars and coordinating domestic and international travel
  • 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.

RaNA Therapeutics is a growing biopharmaceutical company with sites in Cambridge, MA and Lexington, MA. We are seeking a motivated and customer service oriented Systems Engineer to join our small IT team. The successful candidate will report to the IT Manager and will play an integral role in the ongoing management of and build out of RaNA’s IT capabilities. This position is well suited to an individual that has a strong technical foundation, the ability to work autonomously, and aspirations to broaden their skill set while working in an extremely fast-paced environment where priorities will often shift. If you are seeking a role where you will have the opportunity join an IT team on the ground floor, we’d like to talk to you!

Primary Responsibilities                                     

  • Perform system configurations, software installations, updates, and upgrades to Windows servers and other infrastructure systems
  • Create GXP supporting documentation
  • Provide daily operational support and troubleshooting for Windows server and infrastructure applications
  • Monitor system performance/availability and take appropriate proactive steps to maximize uptime
  • Monitor system security and take appropriate steps to resolve security breaches and prevent future attacks
  • Perform backup operations for organization by supporting current backup environment
  • Work with various IT teams to develop hardware and software specifications for new and upgraded systems
  • Designs, installs, configures, maintains and performs system integration testing of PC/server operating systems
  • Supports web access and electronic messaging systems, and maintains a secure system environments
  • Perform system backups and recovery and monitor system configuration to ensure data integrity and confidentiality
  • Keep current on emerging technologies and standards
  • Provide backup support for centralized administration & operations
  • Provide after-hours on-call support
  • Ensures that all systems and infrastructure applications comply with HIPAA security and privacy rules
  • Perform other duties as assigned

Qualifications

  • Bachelor’s Degree in a technical discipline (Computer Science, MIS, or similar) is preferred
  • 3 to 5 years of proven experience (including at least 2 in the life sciences, biotechnology, or pharmaceutical industry) administering Microsoft Windows operating system and infrastructure applications to include: Windows 2003/2016, IIS 5.0/6.0/7.0; Exchange 365/2016; Oracle 11gr2 -12 c1
  • Strong working knowledge of Active Directory, Group Policy, and other key Microsoft administration concepts to include: Microsoft Terminal Services, Azure, office 365, MDM, Cloud Backup (e.g. Iron Mountain).
  • Experience with Dell, servers and/or Lenovo hardware to include Servers; SAN/NAS storage Exablox; RAID; PCs and Laptops.
  • Experience with virtualization technologies like: VMWare, and/or Xen OS.
  • Demonstrated working knowledge of Networking concepts: DNS, DHCP, SMTP, SNMP, TCP/IP. Scripting technologies: Perl, PowerShell, VBScript, and Windows Batch o Security technologies: host-based security; SFTP, SSH; TrendMicro  Anti-virus, Malware Spyware removal tools, bit locker or PGP Encryption.
  • Experience designing and creating specification documents for servers
  • Experience with creating GXP documentation IQ/OQ/PQ etc.
  • Experience administering system disaster recovery plans including testing and execution with procedure documentation
  • Experience gathering requirements
  • Certificate/License: MCSE or MCSA preferred, or CCNA but not required

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 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.  This experienced professional will provide support to the R&D leadership team. 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 Scientific 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. Daily activities will require thorough knowledge of company operations, policies and procedures.

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, including executive support
  • Pharmaceutical or biotech industry experience is preferred
  • Highly proficient in MS Outlook, Word, Excel, PowerPoint
  • Excellent oral and written communication, time management and organization skills
  • Prior experience managing complex calendars and coordinating domestic and international travel
  • 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.