Senior Director, Global Safety Physician

Madrigal Pharmaceuticals seeks a Senior Director, Global Safety Physician to oversee clinical and post-market safety for investigational and approved therapeutics. The role involves signal detection, benefit-risk assessment, regulatory document authorship, and cross-functional collaboration within a growing biopharmaceutical organization.

Responsibilities

• Lead medical oversight and interpretation of safety signals from clinical trials and spontaneous reports
• Author or review safety-related regulatory documents including DSURs, PBRERs, RMPs, and clinical study reports
• Chair or participate in Safety Management Teams for benefit-risk assessments and mitigation strategies
• Collaborate across Clinical Development, Regulatory Affairs, and Biostats on safety strategy alignment
• Support regulatory filings, health authority interactions, and inspection readiness activities

Requirements

• MD or equivalent medical degree with licensure or eligibility
• 15+ years industry experience in clinical safety, pharmacovigilance, or biotech/pharma
• Deep knowledge of GCP, ICH E2E, GVP modules, and global regulatory expectations
• Proficiency with safety databases (Argus, ArisGlobal), MedDRA, and signal detection tools
• Demonstrated leadership across Phase I-IV studies and post-marketing surveillance
• Strong executive communication and strategic decision-making capabilities
• Familiarity with FDA, EMA, PMDA regulatory interactions

Compensation: $318,000 - $388,000 base per year