Senior Director, Global Aggregate Reporting and Risk Management Plans

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 Global Aggregate Reporting & Risk Management Plans is a key leader responsible for providing strategic oversight and operational leadership of pharmacovigilance activities across Madrigal’s aggregate reporting and risk management plans. This individual will build and develop processes for the development, maintenance and tracking/monitoring aggregate reporting and risk management plans, playing a key role in ensuring patient safety. The role will also support global filings (e.g. Marketing Authorization Applications) from a pharmacovigilance perspective. The role will collaborate closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Medical Writing, Biostatistics, 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 review of aggregate data and author/oversee aggregate reports and Risk Management Plans (RMPs), and safety sections of global Marketing Authorization Applications
• Ensure a company core RMP is in place and maintained as new safety data becomes available to serve as the company position when filing in new global markets
• Provides scientific and regulatory guidance on adverse event assessment, benefit-risk evaluation, risk management planning
• Leads/Oversees and contributes to the preparation and review of key safety deliverables, including:
  • Development Safety Update Reports (DSURs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Risk Management Plans (RMPs)
  • Safety sections of INDs, NDAs, MAAs, BLAs, CTAs

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

Specialized Knowledge & Skills:

• Proven ability to plan, coordinate and successfully execute preparation of aggregate safety reports (e.g. DSUR, PADER, PBRER, etc)
• Extensive experience preparing, maintaining and tracking/monitoring the content of Core and Regional Risk Management Plans (RMPs)
• Experience preparing Clinical Safety documents for global MAA submissions (e.g. Integrated Summary of Safety, Summary of Clinical Safety, etc.) and Information Request responses
• Demonstrated ability to ensure governing SOPs are compliant with global regulatory requirements
• Anticipates the necessary resources are available for planned and ad hoc aggregate reports, RMPs and Information Requests to ensure high quality, timely deliverables
• Extensive experience managing team and/or vendors responsible for aggregate reports and RMPs
• 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
• 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
• Possesses computer skills to support use of electronic systems and development of writing deliverables

Educational Requirements:

• Minimum Bachelor's degree in relevant scientific discipline required
• 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
• Familiarity with safety systems (e.g., Argus) and EDC platforms

Madrigal’s Total Rewards strategy is based on a biotech industry peer group comp