Senior Director, Global Safety Physician

Madrigal Pharmaceuticals•Waltham, MA

34d•$318,000 - $388,000

About The Position

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. Position Responsibilities: The Director/Sr Dir, Global Safety Physician plays a key role in ensuring patient safety in clinical studies and those receiving marketed products. This role is responsible for continuous assessment of safety data, signal detection, and benefit-risk evaluation for assigned compounds in development and in the postmarketing setting. The role requires strong collaboration within Global Clinical Safety and Pharmacovigilance and across Clinical Development, Regulatory Affairs, Biostats, and Clinical Operations, with leadership and key contributions to regulatory filings and global safety governance activities. The Director/Sr Dir will serve as a medical expert for safety matters, supporting both investigational and marketed products. Additionally, the role will lead clinical safety strategy, author and review safety-related documents and responses to health authority queries, and support regulatory interactions.

Requirements

The applicant should be a dynamic leader who thrives within a fast-paced, growing, and collaborative, publicly owned biopharmaceutical company:
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
Excellent strategic thinking, problem-solving, and influencing skills
Deep knowledge of FDA, EMA, PMDA and other regulatory body interaction
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 language
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

Nice To Haves

Specialty training in relevant therapeutic areas a plus

Responsibilities

Medical Oversight & Signal Management 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.
Regulatory & Scientific Contributions 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.
Cross-functional Collaboration 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.

Benefits

All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for 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 stake in the organization.
Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans.
We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings.
In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family.
The company also provides other benefits in accordance with applicable federal, state, and local laws.

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