Senior Director, Global Safety Physician
Madrigal Pharmaceuticals · Conshohocken -, PA
SafetyFull-time$318k–$388kCompany career page
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
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