Director, Compliance Operations

Role 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 role serves as a cross-functional business partner, embedding compliance principles into business operations while enabling proactive risk mitigation and regulatory readiness. It balances hands-on program execution with leadership responsibilities, shaping compliance infrastructure to scale with the organization.

Responsibilities

• Lead the development, implementation, and continuous improvement of compliance operations infrastructure that supports an ethical culture across the organization.
• Serve as a strategic partner to business functions, translating 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; apply insights to refine program elements.
• Build relationships 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, 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 multiple priorities in a dynamic environment.
• Travel up to ~25%, including occasional overnights for field monitoring or business meetings.