Senior Director, Global Safety Physician

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.

Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).

Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way.

The Senior Director, Global Safety Physician provides medical safety leadership for assigned investigational and marketed products, with accountability for medically sound safety assessments, ongoing benefit-risk evaluation, and timely recommendations to protect patients. The role partners closely with safety scientists, Clinical Development, Regulatory Affairs, Biostatistics, and Clinical Operations, contributing to regulatory submissions and safety governance.

The Senior Director serves as a medical expert and strategic advisor for assigned programs, leading medical safety strategy, reviewing critical safety documents, and supporting health authority interactions. The role provides timely escalation of significant risks and mentors colleagues as appropriate.

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Key Responsibilities**

Medical Oversight & Signal Management

• Provide medical oversight of assigned products, including review and interpretation of safety data from clinical trials, post-marketing sources, and scientific literature.

• Provide medical leadership in the evaluation and management of safety signals, working with safety scientists responsible for routine surveillance and process execution.

• Assess emerging safety findings, determine their medical significance, and recommend appropriate risk mitigation and regulatory actions.

• Lead medical benefit-risk assessments for assigned products, integrating clinical, nonclinical, and post-marketing evidence to inform development and lifecycle decisions.

• Serve as a key member or designated chair of Safety Review Teams (SRTs), presenting evidence-based recommendations and escalating significant issues through established governance.

Regulatory & Scientific Contributions

·       Author or medically review safety content in key regulatory documents, including DSURs, PBRERs, RMPs, IBs, clinical study reports, and regulatory submissions.

·       Provide medical safety expertise for regulatory filings and interactions, including INDs, NDAs/BLAs, marketing authorization applications, and responses to health authority inquiries.

·       Contribute to product safety information, labeling, and risk management strategies throughout the product lifecycle.

·       Support inspections and audits as the medical safety subject-matter expert, ensuring assessments, decisions, and supporting documentation are scientifically defensible and inspection-ready.

·       Maintain awareness of emerging scientific evidence...

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