Executive Medical Director, SERM

Sarepta Therapeutics seeks an Executive Medical Director for Safety & Risk Management to lead safety oversight and pharmacovigilance activities across investigational and marketed genetic medicine products. The role involves medical leadership of safety teams, clinical trial safety management, regulatory submissions, and risk minimization strategy in a matrix organization.

Responsibilities

• Lead safety scientists and physicians; oversee safety, pharmacovigilance, and risk management for assigned products
• Provide medical guidance on safety matters in clinical development; manage safety alerts, risk management plans, and safety evaluations
• Conduct medical review of adverse events, periodic safety reports, and individual case reports from post-marketing sources
• Lead benefit-risk discussions and risk minimization strategy; design and oversee REMS programs and compliance
• Contribute to clinical safety sections of regulatory submissions including NDAs and marketing applications

Requirements

• M.D. with general medicine knowledge and clinical practice experience
• 7+ years pharmacovigilance experience in clinical and post-marketing settings
• Competency in clinical safety data review including adverse events, protocols, and study reports
• Knowledge of GVP, GCP, ICH guidance, and safety regulations
• Excellent written and oral communication skills with matrix collaboration ability
• Strong judgment and attention to detail in identifying and communicating safety concerns