Senior Director, Global Safety Physician
Madrigal Pharmaceuticals
Full-time
Remote friendly (Conshohocken, PA)
United States
Medical Affairs
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Role Summary
Senior Director, Global Safety Physician responsible for patient safety in clinical studies and for marketed products, including continuous assessment of safety data, signal detection, and benefit–risk evaluation. Leads clinical safety strategy and regulatory interactions, and collaborates with cross-functional teams to support regulatory filings and global safety governance.
Responsibilities
- Provide medical oversight for clinical safety signals, including review and interpretation of safety data from clinical trials, spontaneous reports, and literature.
- Lead or participate in safety signal detection, evaluation, validation, and documentation in collaboration with safety scientists and other stakeholders.
- Serve as a key member or chair of Safety Management Teams (SMTs), contributing to benefit–risk assessments and mitigation strategies.
- Author or medically review safety content in critical regulatory documents such as DSURs, PBRERs, RMPs, IBs, and safety sections of clinical study reports.
- Provide expert medical input for regulatory filings and interactions, including INDs, NDAs/BLAs, and safety responses to agency queries.
- Support inspection readiness and audit activities related to clinical safety documentation.
- Partner with Clinical Development, Biostats, and Regulatory Affairs to align on safety strategy and ensure scientifically sound decision-making.
- Collaborate with PV Operations, Safety Data Management, and Medical Review teams to ensure quality and consistency in safety case evaluations.
- Participate in internal governance forums such as Safety Review Committees (SRCs) or benefit–risk assessment boards.
Qualifications
- MD or equivalent medical degree with licensure or eligibility for licensure
- 15+ years of combined, relevant experience in industry, clinical safety, pharmacovigilance, or related roles within biotech/pharma
- Deep knowledge of GCP, ICH E2E, GVP modules, and global regulatory safety expectations
- Proven track record of leadership across phase I–IV studies and familiarity with post-marketing surveillance processes
- Experience with safety database systems (e.g., Argus, ArisGlobal), MedDRA, and safety signal detection tools
- Experience in a matrixed global environment
- Specialty training in relevant therapeutic areas is a plus
- Excellent strategic thinking, problem-solving, and influencing skills
- Deep knowledge of FDA, EMA, PMDA and other regulatory body interactions
Skills
- Senior-level leadership and communication skills
- Strategic thinker with deep scientific and regulatory knowledge
- Sound judgment in risk–benefit evaluation
- Ability to make decisions in uncertainty
- Ability to influence and align cross-functional stakeholders at all levels
- Ability to deliver executive briefings and board-level updates
- Ability to anticipate and resolve problems effectively
- Strong verbal communication and technical writing skills
- Ability to present clearly using scientific and regulatory terminology
- Fluent in English
Education
- MD or equivalent medical degree with licensure or eligibility for licensure
- 15+ years of combined, relevant experience in industry, clinical safety, pharmacovigilance, or related roles within biotech/pharma