Associate Director, Global Aggregate Reporting & Risk Management Plans

Madrigal Pharmaceuticals • Conshohocken, PA

4d

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. The Associate Director, Global Aggregate Reporting & Risk Management Plans supports the strategic and operational execution of pharmacovigilance activities related to aggregate reporting and risk management planning across Madrigal’s portfolio. This role is responsible for hands-on preparation, coordination, and review of aggregate safety reports and risk management plans, ensuring high-quality, compliant, and timely safety deliverables. Reporting to the Senior Director, Global Aggregate Reporting & Risk Management Plans , this role works cross-functionally with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Writing, Biostatistics, Medical Affairs, and external pharmacovigilance vendors to support global safety requirements and maintain a robust safety infrastructure. The Associate Director brings strong pharmacovigilance expertise, scientific judgment, and operational rigor, and plays a key role in scaling safety processes within a dynamic, growing biopharma environment.

Requirements

• Demonstrated experience planning, coordinating, and executing aggregate safety reports (e.g., DSURs, PADERs, PBRERs)
• Working knowledge of the development, maintenance, and lifecycle management of Core and Regional RMPs
• Solid understanding of global pharmacovigilance regulations and reporting requirements
• Strong scientific and clinical acumen with the ability to synthesize safety data and clearly communicate risk
• Highly organized, detail-oriented, and capable of managing multiple deliverables in a fast-paced environment
• Effective collaborator with the ability to work across matrixed teams and with external vendors
• Comfortable operating with increasing autonomy while escalating issues appropriately
• Ability to apply SOPs consistently and support compliance with evolving regulatory expectations
• Proficient with electronic safety systems and document management tools (e.g., Argus, document authoring platforms)
• Minimum Bachelor’s degree in a relevant scientific discipline required
• Minimum of 10 years of experience in clinical safety or pharmacovigilance within the pharmaceutical or biotechnology industry
• Demonstrated experience contributing to aggregate safety reporting and risk management activities
• Prior experience working with safety databases and systems (e.g., Argus)

Nice To Haves

• Advanced degree preferred (e.g., PharmD, PhD, NP/PA)
• Previous experience supporting global regulatory submissions is a plus
• Previous experience collaborating with external vendors is a plus

Responsibilities

• Serve as primary author for assigned aggregate safety reports (e.g. Development Safety Update Reports [DSURs], Periodic Adverse Drug Experience Reports [PADERs], Periodic Benefit-Risk Evaluation Reports [PBRERs]) and Risk Management Plans (RMPs) by coordinating process steps from drafting through finalization for submission.
• Serve as a key contributor to the maintenance and tracking/monitoring of the company Core RMP and regional RMPs as new safety data emerge
• Under the direction of the Senior Director, support global marketing authorization submissions and responses to regulatory information requests from a pharmacovigilance perspective
• Ensure adherence to SOPs, global regulatory requirements, and inspection readiness for aggregate reporting and RMP activities
• Identify opportunities for process improvements and contribute to the continued optimization of aggregate reporting and RMP processes
• Other duties as assigned

Benefits

• 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 stake in the organization.
• All employees receive equity, which we believe reinforces our ownership culture.
• Full-time employees are eligible for bonus, equity and comprehensive benefits including flexible paid time off (in the form of 4 weeks’ vacation time, 1-week sick time, and 2 float days), medical, dental, vision and life/disability insurance, and leave benefits in accordance with federal, state, and local laws.
• We also offer Voluntary benefits like life insurance, retirement benefits i.e. 401(k), pre-paid legal and supplemental insurance.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees