Senior Director, Global Safety Physician
Core
Lead global clinical safety strategy, signal detection, and benefit-risk evaluation for investigational and marketed biopharmaceutical products.
Role type
Senior Director, Global Safety Physician (Medical Expert)
Builds
Safety strategies, regulatory filings (DSURs, PBRERs, RMPs), and safety responses for MASH therapeutics.
Domain
Biopharmaceuticals / Clinical Safety & Pharmacovigilance
Required skills
GCP, ICH E2E, GVP modules, safety signal detection, regulatory interaction (FDA/EMA/PMDA), strategic thinking, risk-benefit evaluation, technical writing
Preferred skills
Specialty training in metabolic/liver diseases, experience with Argus/ArisGlobal/MedDRA, board-level briefing capability
Technologies
Argus, ArisGlobal, MedDRA
Responsibilities
Lead safety signal detection and validation; author and review critical regulatory safety documents; chair Safety Management Teams (SMTs); support regulatory interactions and inspection readiness; collaborate cross-functionally on safety strategy.
Seniority
Senior Director, executive leadership