Senior Director, Global Safety Physician

Senior Director, Global Safety Physician
Компания: Madrigal Pharmaceuticals
Город: Waltham
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, therapeutic developments, and regulatory expectations relevant to assigned products.
**Cross-functional Collaboration**
· Provide proactive medical safety input into clinical development plans, study protocols, safety monitoring, stopping rules, and risk mitigation strategies.
· Develop and execute medical safety strategy for assigned products and studies, partnering with Clinical Development, Biostatistics, Regulatory Affairs, and other stakeholders.
· Evaluate emerging safety data to inform clinical development decisions and recommend changes to monitoring or risk management as appropriate.
· Serve as an escalation point for complex or clinically significant safety cases from internal and external medical review teams; collaborate with PV Operations and safety scientists to support consistent evaluations.
· Provide medical safety expertise to cross-functional governance committees and collaborate with Medical Affairs on relevant post-marketing safety activities.
· Communicate safety findings, benefit-risk considerations, and actionable recommendations clearly to cross-functional teams, safety governance forums, and senior leadership.
· Exercise independent medical judgment, constructively challenge assumptions, and influence decisions through balanced scientific reasoning.
· Identify and escalate significant safety concerns promptly, providing clear, actionable recommendations.
· Foster collaboration, scientific rigor, accountability, and continuous improvement across safety activities.
· Mentor safety physicians and scientific colleagues, sharing medical expertise and supporting their development; manage direct reports where assigned.
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Experience and Professional Qualifications**
The successful candidate will combine strong clinical judgment, scientific rigor, and collaborative leadership with the ability to make independent, well-supported safety recommendations in a growing biopharmaceutical company.
**Required Qualifications**
· MD or equivalent medical degree, completion of relevant clinical training, and substantial experience in clinical safety, pharmacovigilance, or pharmaceutical clinical development.
· Approximately 15 or more years of relevant combined clinical and pharmaceutical industry experience, including meaningful experience in drug safety or pharmacovigilance.
· Demonstrated medical safety leadership on clinical development programs, including relevant experience with post-marketing safety assessment.
· Strong understanding of global safety regulations and guidelines, including GCP, ICH E2 guidelines, EU GVP, and FDA requirements.
· Expertise in safety signal evaluation, medical causality assessment, benefit–risk assessment, and risk mitigation.
· Experience preparing or medically reviewing safety content for regulatory submissions and participating in safety governance and health authority interactions.
· Working knowledge of safety databases (e.g., Argus, ArisGlobal), MedDRA, and safety surveillance methodologies.
· Demonstrated ability to work effectively in global, matrixed organizations and influence cross-functional decisions.
· Strong clinical reasoning, analytical judgment, and problem-solving skills, including timely recommendations when evidence is incomplete or conflicting.
· Excellent written and verbal communication skills, including the ability to present complex medical and scientific information clearly to diverse audiences.
**Preferred Qualifications**
· Specialty training (including board-certification) or relevant clinical experience in therapeutic areas aligned with the company's portfolio.
· Experience with global regulatory submissions and interactions with FDA, EMA, PMDA, or other major health authorities.
· Experience chairing or contributing to multidisciplinary safety governance meetings.
· Experience mentoring safety physicians or scientific colleagues; prior people-management experience is a plus.
· Experience in a growing biotechnology or specialty pharmaceutical organization.
Madrigal’s Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a s