Executive Medical Director - SERM
$313.2k - $391.5k/yr
Senior
MD
Cambridge, MA, USA
HybridHybrid; expected to work on site at a Sarepta facility in the United States and/or attend company-sponsored in-person events from time to time.
Biology & Biotech
About the job
Requirements
- An M.D. with solid knowledge and clinical practice experience in General Medicine is required.
- Experience in medical safety activities within pharmacovigilance for products in clinical trials and post-marketing is required.
- At least 7 years of pharmacovigilance experience is required.
- Competence in safety reviews of clinical safety data and documents, including adverse events and serious adverse events, investigator brochures, protocols, clinical study reports, informed consent documents, and clinical safety submissions, is required.
- Competence in safety reviews of post-marketing safety documents, including spontaneous reports, individual case safety reports, periodic safety reports, risk management plans, and company core data sheets, is required.
- Knowledge of Good Pharmacovigilance Practices, Good Clinical Practice, International Council for Harmonisation guidance, and safety regulations is required.
- The ability to communicate and collaborate effectively in a matrix environment is required.
- Strong written and oral communication skills are required.
- Good judgment and decision-making skills, including identifying and communicating relevant safety issues or concerns to Pharmacovigilance and Risk Management management appropriately and promptly, are required.
- The ability to multitask and close attention to detail are required.
- Candidates must be authorized to work in the United States.
Responsibilities
- Represent Pharmacovigilance and Risk Management in clinical development projects by providing expert medical guidance on safety matters for investigational products and communicating or producing safety alerts and signals, development risk management plans, reference safety information, and evaluations of emergent safety issues.
- Provide medical safety oversight in clinical trials, participate in protocol development focused on safety data collection and monitoring in interventional and observational studies, medically review adverse events and serious adverse events, and evaluate safety data and statistical analysis planning and reporting.
- Contribute to preparation and review of periodic safety reports, including Development Safety Update Reports and Expanded Access Program reports.
- Contribute to the activities of Data and Safety Monitoring Boards and safety-event adjudication committees.
- Contribute to analysis of safety data from ongoing and completed studies and its presentation in clinical study reports.
- Lead the Investigator Brochure “Guidance for Investigators” section and other safety sections.
- Lead clinical safety content for country marketing applications, including New Drug Application and Marketing Authorization Application Clinical Safety Summaries and REMS or risk management plans.
- Oversee medical review of individual case safety reports from post-marketing sources.
- Lead product risk management strategy and facilitate production and maintenance of risk management plans.
- Participate in the signal management system through regular review of safety data for assigned products and detection and evaluation of new safety signals.
- Provide medical input to the design and maintenance of Risk Evaluation and Mitigation Strategy programs, monitor REMS goals, and provide REMS Assessment Reports.
- Lead benefit-risk discussions at the safety governance committee and implement risk-minimization actions.
- Conduct medical evaluation of relevant safety-related information from toxicology and nonclinical studies, as well as product quality complaints, as needed.
- Contribute to preparation and review of periodic safety reports, including FDA Enhanced Pharmacovigilance Plan reports and Periodic Benefit-Risk Evaluation Reports.
- Provide leadership for safety physicians and safety scientists in the SERM group.
- Participate in leadership oversight of safety vendors and provide backup for the Head of Pharmacovigilance and Risk Management.
- Participate in continuous improvement activities for self and the Pharmacovigilance and Risk Management department, including systems design and quality management activities.
- Contribute to development of the Pharmacovigilance and Risk Management department through recruiting and coaching talent and fiscal management.
About the company
Sarepta Therapeutics focuses on developing precision genetic medicines to treat rare diseases. It specializes in Duchenne muscular dystrophy (DMD) and is advancing gene therapies for limb-girdle muscular dystrophy (LGMD), Charcot-Marie-Tooth disease, MPS IIIA, and other CNS disorders. The company conducts research and development, carries therapies through clinical trials, and seeks regulatory approvals to bring treatments to patients, earning revenue from approved therapies and strategic partnerships. Its goal is to speed up drug development from lab research to patient treatment and to build the world’s largest gene therapy manufacturing capacity to meet global demand.
Company Size
1,001-5,000
Company Stage
IPO
Headquarters
Cambridge, Massachusetts
Founded
1980
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Simplify's Take
What believers are saying
- FDA accepted AMONDYS 45 and VYONDYS 53 sNDAs; PDUFA lands February 28, 2027.
- ENDEAVOR Cohort 8 enrollment finishes by year-end 2026, with Q1 2027 readouts.
- Restructuring cut 36% of staff, targeting $400 million annual savings starting 2026.
What critics are saying
- ELEVIDYS carries a boxed liver-injury warning; FDA may keep non-ambulatory patients excluded.
- Q2 2026 ELEVIDYS revenue fell to $98.1 million after the 2025 safety reset.
- If ENDEAVOR fails, Sarepta becomes a shrinking PMO company facing 2027 stagnation.
What makes Sarepta unique
- Sarepta owns the deepest DMD franchise, spanning PMOs and ELEVIDYS commercialization.
- Roche partnership supplies ex-U.S. manufacturing revenue and global Duchenne reach.
- Michael Severino joined July 28, 2026, bringing AbbVie-style franchise execution discipline.
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Benefits
- Wellness Program