Director, Compliance Operations

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.

Job Summary:

The Director, Compliance Operations is a key strategic and operational leader responsible for driving the execution and continuous enhancement of Madrigal’s enterprise Compliance Program.  This individual serves as a cross-functional business partner, embedding compliance principles into business operations while enabling proactive risk mitigation and regulatory readiness.

This role balances hands-on program execution with leadership-level responsibilities, contributing to long-term functional strategy, influencing key stakeholders, and shaping compliance infrastructure to scale with the organization’s growth. The ideal candidate brings deep pharmaceutical compliance expertise, a collaborative mindset, and the ability to lead initiatives in a fast-paced, evolving environment.

Key Responsibilities

• Lead the development, implementation, and continuous improvement of compliance operations infrastructure that supports a strong ethical culture across the organization.
• Serve as a strategic partner to business functions, translating complex regulatory requirements into actionable, risk-based compliance solutions.
• Oversee the management, optimization, and adoption of compliance tools, dashboards, and reporting systems to monitor program effectiveness.
• Facilitate Executive Level Contributions Review Committee meetings, including agenda planning, tracking action items, and synthesizing outcomes for executive visibility.
• Collaborate with Legal, Medical, Commercial, and other stakeholders to review, assess, and document high-risk activities (e.g., HCP engagements, sponsorships, advisory boards).
• Provide direction for the development and dissemination of compliance policies, SOPs, and guidance—ensuring alignment with regulatory expectations and business needs.
• Design and deliver targeted, role-specific compliance training and communications that support awareness, accountability, and behavioral change.
• Support enterprise risk assessment processes, including data analysis, stakeholder engagement, and remediation tracking.
• Analyze outcomes from audits, investigations, and monitoring activities, identifying themes and advising on continuous improvement opportunities.
• Stay abreast of evolving healthcare laws, regulations, and enforcement trends (e.g., OIG, DOJ, PhRMA, state-level requirements); apply insights to refine program elements.
• Build relationships and influence across functions to embed compliance into strategic and operational planning.
• Lead or contribute to enterprise-wide compliance projects, workstreams, and systems implementations as needed.

Qualifications:

Education

• Bachelor’s degree required; advanced degree (e.g., JD, MPH, MBA) preferred.

Experience

• 9–12 years of progressive experience in pharmaceutical, biotech, or life sciences industry, with at least 3–5 years in a leadership or matrixed role.
• Proven ability to lead cross-functional initiatives and influence at all levels of the organization.
• Strong knowledge of healthcare compliance frameworks, regulatory requirements, and industry codes.
• Experience building or scaling operational compliance tools, systems, and workflows.
• Demonstrated success in policy development, risk assessments, and compliance training programs.
• Excellent written and verbal communication skills; able to convey complex concepts to diverse audiences.
• Strong project management and organizational capabilities; comfortable managing mult