Director, CSPV Business Operations & Communications

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).

Director, CSPV Business Operations & Communications

Department: Research and Development
Location: Waltham, MA - Hybrid, 3 days a week in office

Reports to: SVP, Global Clinical Safety & Pharmacovigilance

About Madrigal:

Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra™ (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.

Madrigal is seeking to become a global biopharmaceutical company and to bring Rezdiffra™ (resmetirom) to patients with nonalcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH).

The company is in an exciting period of rapid growth and has made the decision to expand its drug safety and pharmacovigilance capabilities to match the company’s ambitions.

Position Responsibilities:

The Director, CSPV Business Operations & Communications is a critical leadership role within the Clinical Safety & Pharmacovigilance (CSPV) organization, serving as a direct report to the SVP of CSPV. This role will manage the operational infrastructure of the department, oversee internal communications and governance, and serve as the key business partner to CSPV leadership. This role also will work cross-functionally with Post-Marketing PV, Clinical Safety and International QPPV to ensure cohesive, streamlined execution, resource optimization, and alignment with corporate, regulatory, and functional expectations.

Key Responsibilities

Operational Infrastructure & Planning

• Lead operational strategy and execution across CSPV, including budget planning, headcount tracking, resource allocation, and infrastructure development
• Facilitate internal and cross-functional alignment to support efficient delivery of PV activities throughout the product lifecycle
• Oversee and partner with key stakeholders the development and tracking of departmental dashboards, KPIs, and quarterly business reviews (QBRs) to monitor progress against key goals

Leadership Team Support & Initiative Management

• Serve as chief operating partner to the CSPV Leadership Team (CSPV LT) by organizing LT meetings, tracking action items, and ensuring completion of critical initiatives
• Oversee priority tracking, process reviews, and development of new business processes to improve operational effectiveness
• Coordinate the execution and follow-up of cross-functional projects and strategic initiatives on behalf of the leadership team

Communications & Engagement

• Manage internal communications, including:
  • CSPLT meeting agendas, minutes, and follow-ups
  • CSPV All-Staff meeting and cross-departmental updates
  • Team engagement activities such as trainings, Lunch & Learns, and team-building events
• Own and maintain CSPV’s internal SharePoint site, Teams site and other collaboration tools to enhance knowledge sharing and documentation management

Governance, Compliance & Vendor Oversight

• Support regulatory inspection readiness through organized documentation, audit response coordination, and compliance metric reporting
• Oversee vendor and consultant relationships related to operational support, safety systems, and outsourced business systems

Critical Competencies for Success:

The ideal candidate displays the following professional competencies:

• Sound organizational skills
• Project management skills and focus on delivery of results
• Ability to deliver executive briefings
• Display a sense of urgency; identify challenges and problems and take initiative to identify solutions
• Strong scientific and technical skills
• Strong interpersonal capab