Senior Director, Safety Surveillance

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. 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).

Job Summary:

The Senior Director Safety Surveillance is a key leader responsible for providing strategic oversight and operational leadership of pharmacovigilance activities across Madrigal’s clinical development and marketed programs. This individual will build and develop processes for the evaluation of pharmacovigilance data, playing a key role in ensuring patient safety through proactive safety surveillance, signal detection, and safety governance processes. The role will collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, 7Biostatistics, and external PV vendors as appropriate to maintain a compliant and efficient safety infrastructure. This role requires deep pharmacovigilance expertise, sound clinical judgment, and an owner mindset to scale PV capabilities in a dynamic, growing biopharma environment.

Position Specific Responsibilities:

The key responsibilities for this role are:

· Leads & sets the standard for ongoing surveillance of pharmacovigilance data, including the signal detection process and deliverables, ongoing risk assessment, and benefit-risk evaluations; builds processes, templates and training in support of these activities

· Ensure accurate and up-to-date safety information is contained in key documents such as Company Core Safety Information (CCSI), reference safety information such as local and regional labels and Investigator Brochures

· In collaboration with the PV medical team, author safety topic assessment reports in response to potential safety signals or Health Authority queries

· Ensures preparation (e.g. slide presentations) for cross-functional safety governance meetings; may present key data/analyses at these meetings.

· Support epidemiology work needed to assess and categorize risk

· Ensure consistent application of SOPs, regulatory compliance, and audit/inspection readiness

Specialized Knowledge & Skills:

· Proven ability to build and lead safety sciences function, including experience hiring and managing direct reports

· Deep understanding of pharmacovigilance principles and regulatory frameworks across global markets

· Strong scientific and clinical acumen, with the ability to synthesize safety data and communicate risk clearly; excellent presentation skills

· Skilled at building relationships and influencing across matrixed environments

· Excellent organizational skills with high attention to detail and operational rigor, with comfort managing ambiguity and evolving infrastructure

· Highly experienced in mentoring, developing, and scaling pharmacovigilance teams and processes

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Educational Requirements:

· Advanced degree preferred: PharmD, PhD , NP/PA

Experience:

· Minimum 15+ years of experience in clinical safety or pharmacovigilance within the pharmaceutical or biotechnology industry

· Minimum of 5+ years of direct and indirect people management experience

Compensation: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.

Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.

Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Interviews with Madrigal are conducted via the Zoom platform.

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