Executive Medical Director, SERM

About the role

Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

Responsibilities

• Represents PV & RM in clinical development projects providing expert medical guidance on safety matters for investigational products.
• Responsible for communicating or producing safety alerts/signals, development risk management plans, reference safety information and safety evaluations of emergent safety issues.
• Provides medical safety oversight in clinical trials.
• Participates in protocol development, specifically the collection and monitoring of safety data in interventional and observational studies, medical review of adverse events/SAEs and evaluation of safety data and statistical analysis planning and reporting of study data.
• Contributes to preparation and review of periodic safety reports (DSUR, EAP Reports).
• Contributes to activities of DSMBs and safety events adjudication committees.
• Contributes to analysis of safety data from on-going and completed studies and their representation in clinical study reports.
• Provides leadership for IB section “Guidance for Investigators” and other safety sections.
• Provides leadership on clinical safety content of country marketing applications e.g. NDA/MAA Clinical Safety Summary and REMS/Risk Management Plan.
• Performs medical review oversight for individual case safety reports (ICSRs) from post‑marketing sources.
• Leads product risk management strategy and facilitates production and maintenance of risk management plans.
• Participates in the signal management system with regular review of safety data for assigned products and detection and evaluation of new safety signals.
• Provides medical input to design and maintenance of REMS programs, monitoring of REMS goals and provision of REMS Assessment Reports.
• Leads benefit‑risk discussions at the safety governance committee