Executive Medical Director, SERM
Core
Lead safety scientists and physicians to oversee pharmacovigilance, risk management, and safety data analysis for investigational and marketed products in muscle, CNS, and cardiac disease programs.
Role type
Executive Medical Director (Pharmacovigilance & Risk Management)
Builds
Safety alerts, risk management plans, periodic safety reports, and clinical safety summaries for gene therapies and small molecules.
Domain
Biopharmaceuticals / Genetic Medicine / Rare Diseases (Duchenne muscular dystrophy)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical safety oversight, pharmacovigilance leadership, risk management strategy, safety signal detection, regulatory safety submissions, toxicology evaluation, team leadership, matrix collaboration
Preferred skills
None stated
Technologies
None stated
Responsibilities
Represent PV & RM in clinical development projects providing expert medical guidance on safety matters; Provide medical safety oversight in clinical trials including protocol development and adverse event review; Contribute to preparation and review of periodic safety reports (DSUR, EAP Reports); Provide leadership for IB section "Guidance for Investigators" and other safety sections; Leads product risk management strategy and facilitates production of risk management plans; Conducts medical evaluation of safety-related information from toxicology, non-clinical studies, and product quality complaints; Provides leadership for the safety physicians and safety scientists in the SERM group; Participates in leadership oversight of safety vendors.
Seniority
Executive, strategic leadership & mentorship
