Senior Director, US Compliance

The Opportunity:

The Sr. Director, US Compliance will serve as a strategic compliance business partner across all business functions, reporting to the VP, US Compliance. This role is responsible for shaping compliance strategy and providing proactive compliance advice and counsel as the company prepares for future product commercialization. This role requires a firm understanding of pharmaceutical industry codes and regulations, healthcare laws, and compliance risk assessment and management, as well as a strong ability to advise on interactions with the healthcare community and other external stakeholders. The individual will play an integral part in ensuring company activities are conducted in accordance with applicable healthcare laws, regulations, industry codes, and internal policies while enabling business objectives in a compliant and ethical manner.

The Sr. Director will collaborate cross-functionally with Commercial, Medical Affairs, Clinical Development, Patient Advocacy, Legal, Regulatory, Finance, and other stakeholders to support the compliant execution of Revolution Medicines’ business activities. This role requires the ability to balance operational execution with strategic leadership in a dynamic and evolving organization. 

Key Responsibilities will include:

Product Launch and Healthcare Community Engagement Support

• Provide timely, practical, and risk-based compliance advice and counsel on healthcare compliance and policy requirements related to Revolution Medicines interactions with the healthcare community, including disease education programs, promotional and nonpromotional activities, consulting engagements, advisory boards, external funding, patient assistance programs, patient advocacy group interactions, payer interactions, and other similar activities.

• Support the review and approval of promotional and nonpromotional materials and patient engagement programs to ensure regulatory compliance.

• Advise on compliance with False Claims Act, Anti-Kickback Statute (AKS), Foreign Corrupt Practices Act (FCPA), and state/federal transparency laws.

Collaboration with Healthcare Law

• Partner closely with the Healthcare Law team to ensure consistency between legal interpretation and compliance operations.

• Maintain a clear functional separation of responsibilities between Compliance and Healthcare Law.

• Collaborate to deliver integrated, practical, and risk-appropriate guidance to internal clients – particularly within Commercial, Medical Affairs, Clinical Development, and Market Access functions.

Compliance Risk Assessments, Investigations, and Mitigation

• Identify and escalate compliance risks, and support development of mitigation strategies.

• Support compliance risk assessments related to commercial and medical activities, external stakeholder engagements, and other business activities.

• Support investigations into potential compliance violations, ensuring timely, thorough resolution and corrective actions.

• Support implementation of corrective and preventive actions resulting from monitoring or audit activities.

Training, Communications, and Compliance Program Support

• Support operational execution of healthcare compliance policies and processes.

• Develop and implement risk-based compliance training tailored to various business functions and levels within the organization.

• Promote a culture of ethics and compliance through ongoing communications and awareness initiatives.

• Collaborate with internal stakeholders to identify process improvements and enhance operational efficiency.

• Participate in compliance monitoring, auditing, and remediation activities, as needed.

Governance & Reporting

• Prepare materials and reporting for Compliance Committee and senior leadership.

• Develop and implement policies, procedures, and controls designed to mitigate compliance risk while supporting business needs.

• Assist with the development, management, and reporting of data analytics to manage compliance risks.

• Contribute to the development of annual compliance work plans and strategic priorities.

• Monitor evolving regulatory and industry developments and assess impact on company policies and practices.

Required Skills, Experience and Education:

• J.D. from an accredited US law school and member in good standing of a US State Bar.

• 10+ years of healthcare compliance experience in pharmaceuticals or biotechnology, with in-house compliance experience strongly preferred.

• In-depth understanding of US healthcare laws, including Anti-Kickback Statute, False Claims Act, FDA promotional regulations, FCPA, and relevant industry guidance.

• Experience in designing, implementing, and overseeing key elements of an effective compliance program, including risk assessments, investigations, and compliance business partnership.

• Demonstrated ability to build strong partnerships and collaborate with internal and external partners at all levels of the organization.

• Strategic and pragmatic compliance mindset with strong business acumen.

• High ethical standards and sound judgment, and committed to fostering a culture of integrity, transparency, and continuous improvement.

• Excellent leadership, communication, analytical, and problem-solving skills, with the ability to work collaboratively with legal, scientific, and business functions.

• Strong presentation, organizational, and project management skills, capable of handling multiple high-priority projects simultaneously.

• Team-oriented approach to work, and ability to lead through influence in a dynamic environment.

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