Senior Director, Global Safety Physician

Role: Senior Director, Global Safety Physician, overseeing clinical safety and pharmacovigilance for Madrigal’s MASH therapeutics, including Rezdiffra (resmetirom). Objectives: ensure patient safety through continuous monitoring, signal detection, and benefit-risk assessment in clinical and post-marketing settings. Responsibilities include leading safety signal evaluation, authoring regulatory safety documents (e.g., DSURs, PBRERs), supporting regulatory interactions, and collaborating cross-functionally with Clinical Development, Regulatory Affairs, and PV teams. Qualifications: MD or equivalent with 15+ years in industry, clinical safety, or pharmacovigilance; deep expertise in GCP, ICH E2E, and global safety regulations; proficiency with safety databases and signal detection tools. Preferred: experience with biologics or small molecules in metabolic or liver disease areas, and relevant therapeutic specialty training. High-Value: leadership in late-phase (Phases 2-4) safety monitoring, regulatory submissions, and global safety governance; experience in fast-paced biotech environment; strong strategic, communication, and influencing skills. WorkSetup: Not specified; international regulatory focus implied.