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 capabilities and ability to build and maintain networks
• Ability to anticipate and resolve problems effectively
• Strong verbal communication and writing skills
• Fluent in English language
• Ability to present clearly using scientific and regulatory terminology
• Comfort with ambiguity

Education & Qualifications:

• Bachelor’s degree in life sciences, public health, business, or a related field; advanced degree (MBA, MPH, or equivalent) preferred
• 12-15 years combined experience in drug safety / pharmacovigilance or clinical project management
• 3+ years in a leadership or strategic operations role
• Project Management Professional (PMP) certification a plus
• Experience engaging and overseeing vendors
• Experience supporting both clinical and post-marketing safety teams
• Proficiency in tools PM tools such as Power BI, Veeva Vault, Smartsheet, and SharePoint

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.

Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for Madrigal we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks.