Moderna is seeking a physician to lead clinical trials for one or more of their development programs in Infectious Diseases. Board certification in Infectious Diseases, Internal Medicine, and/or Pediatrics is desirable. Research and industry experience in vaccine development is a plus.
This role will report to Moderna’s Head, Translational Medicine, Infectious Diseases, and will be the primary point person for the medical oversight of clinical studies with responsibilities to include clinical trial design, protocol development, Sponsor medical monitoring, review and interpretation of clinical trial data, and timely execution of deliverables in close collaboration with relevant internal and external partners. The position is based at Moderna’s Cambridge, MA site.
The successful candidate is driven, curious, collaborative, with a bold ambition to contribute to the development of ground-breaking mRNA-based vaccines. Excellence in communication, teamwork, and collaboration is a must.
Here’s What You’ll Do:
- Provide clinical scientific leadership in the clinical trial team.
- Provide medical leadership for cross-functional internal workstreams including pharmacovigilance, biostatistics, clinical operations, and regulatory affairs.
- Either directly monitor or provide medical safety oversight of CRO medical monitors.
- Collaborate with partners in the pharmacovigilance department in the analysis of clinical trial safety data.
- Collaborate closely with partners in the Clinical Operations, and be accountable for clinical trial conduct and timelines for associated key deliverables.
- Lead the design and writing of clinical protocols and associated clinical documents.
- Lead the writing of clinical and safety sections of key Program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, Development Safety Update Reports, Biologics License Applications, and other regulatory submissions and responses.
- Be responsible for the preparation, analysis, and presentation of safety data to internal and external safety monitoring boards.
- Assume primary responsibility for the preparation of meeting abstracts, posters, and presentations related to clinical trial data.
- Contribute to the writing of manuscripts and publications.
- Comply with Moderna SOPs and adhere to ICH, GCP, and relevant regulatory guidelines.
- Provide medical leadership for internal audits and regulatory inspections.
- Assist in preparations of materials for Advisory Board meetings.
- Develop and maintain strong, collaborative relationships with the broader Moderna organization.
- Represent Moderna externally to trial site Investigators and administrators.
Here’s What You’ll Bring to the Table:
- MD or non-US equivalent of MD degree with completion of residency in Internal Medicine, Pediatrics Family Practice, or Obstetrics/Gynecology. Completion of a fellowship, clinical research experience, or focused training in Infectious Diseases is desirable.
- Minimum 3 years’ experience in early- to late-stage development in an academic or industry setting. Proven ability to:
- Plan and conduct clinical trials
- Deliver high-quality results within established timelines
- Demonstrated track record in leading cross-functional teams and work streams (pharmacovigilance, biostatistics, clinical operations, and regulatory affairs).
- Ability to thrive in a fast-paced environment.
- Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.
- Excellent analytical, problem-solving and strategic planning skills.
- Strong interpersonal skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions.
- Exceptional written and oral communication skills to meet the needs of varied audiences.
- Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies is desirable.
Here’s What We’ll Bring to the Table:
- On-site subsidized cafeteria or catered lunches
- Company-provided iPhone
- Free parking, monthly subway pass or a subsidized commuter rail pass
- Free annual corporate membership to Bluebikes
- Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
- Flexible Spending Accounts for medical expenses and dependent care expenses
- 16 weeks of 100% paid parental leave for all new parents
- 16 weeks 100% paid family caregiver leave
- 20 weeks 100% paid medical leave
- Eligible for “Moderna Month” (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
- Adoption assistance and discounts to local childcare centers, as well as access to care.com
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
- Voluntary legal assistance plan
- 15 days’ vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science’s list of top biopharma industry employers for the past five years.