Executive Medical Director, SERM

Role: Executive Medical Director, SERM, providing leadership for safety scientists and physicians overseeing pharmacovigilance and risk management for Sarepta's investigational and marketed products, primarily in genetic therapies for Duchenne muscular dystrophy and other muscle, CNS, and cardiac diseases. Responsibilities: lead safety activities across clinical trials and post-marketing, including safety data review, signal detection, safety report preparation (DSUR, PBRER), oversight of DSMBs, risk management strategies, and safety content in regulatory submissions; manage safety vendors and participate in safety governance. Qualifications: MD with 7+ years in pharmacovigilance, strong clinical medicine background, experience with safety activities in clinical and post-marketing phases, proficiency in safety data review, GVP, GCP, ICH guidelines, and safety regulations; excellent communication and decision-making skills. High-Value: focus on genetic medicines, Duchenne therapies, clinical safety in early and later development stages, regulatory safety submissions, and cross-functional stakeholder engagement. WorkSetup: hybrid US-based role requiring onsite presence and occasional in-person events; salary range $313,200 - $391,500.