Senior Director, Compliance

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team you will join other outstanding Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Senior Director Compliance will provide enterprise-wide compliance leadership and support across Revolution Medicines frequently interacting with and providing compliance advice to Commercialization Clinical Manufacturing Research and Development and all corporate (G&A) functions.

The Senior Director Compliance will support the Vice President Compliance to implement and continuously enhance a comprehensive compliance program that spans healthcare research manufacturing export controls economic sanctions trade and tariff-related compliance general corporate compliance and other global business conduct requirements applicable to a growing multinational organization.

Reporting to the Vice President Compliance this individual will serve as a trusted advisor to senior leaders and cross-functional teams embedding compliance into daily operations while supporting the companys growth as commercial stage oncology organization.

Key responsibilities will include:

Enterprise & General Corporate Compliance

• Support the VP Compliance in maintaining the Compliance Committee and integrating the compliance program into all business operations including Commercialization Research and Development G&A functions (Finance HR IT Procurement and Facilities).

• Provide compliance oversight and advisory support for general corporate risk areas including conflicts of interest third-party risk management anti-bribery and corruption data privacy records management and ethical business practices.

• Partner with Finance HR IT and other corporate stakeholders to identify assess and mitigate enterprise compliance risks.

• Provide guidance on export control laws and regulations (including Export Administration Regulations (EAR) and Office of Foreign Assets Control (OFAC) requirements) sanctions list screening and trade compliance considerations related to cross-border activities research collaborations technology transfers and supply chain operations.

• Partner with Supply Chain Manufacturing IT and Research teams to identify and mitigate risks related to tariffs customs classifications import/export restrictions and international shipping of materials data and technology.

• Support development and implementation of policies procedures and controls related to trade compliance including restricted party screening license determinations and escalation processes.

Clinical Manufacturing & Research Compliance

• Provide compliance guidance and oversight to Clinical Development Clinical Operations Manufacturing Quality Supply Chain Biomedical Discovery and Early Discovery functions.

• Support Quality and Regulatory departments with compliance related to GxP environments including GCP GMP and GLP activities.

• Advise Research & Development departments on compliance considerations related to research collaborations investigator engagements material transfers data integrity and third-party relationships.

• Support compliance risk assessments and monitoring activities across preclinical research clinical trials and manufacturing operations.

Healthcare & Commercial Compliance

• Provide compliance support for Commercial Marketing Medical Affairs Market Access and Regulatory Affairs on matters including FDA regulations Anti-Kickback Statute False Claims Act OIG guidance Sunshine Act and industry codes.

• Ensure alignment between healthcare compliance requirements and broader corporate compliance controls.

Program Leadership & Execution

• Support the VP Compliance in the development and continuous enhancement of a risk-based effective enterprise compliance program aligned with DOJ guidance and industry best practices.

• Establish update and enforce compliance policies procedures standards and tools applicable across corporate R&D clinical manufacturing and commercial functions including policies addressing export controls sanctions compliance and international trade requirements.

• Support the development implementation and management of compliance and audit work plans including monitoring activities and Corrective Action Plans.

• Implement and manage compliance monitoring programs analyzing trends identifying risk areas and making strategic recommendations for continuous improvement including monitoring of internal controls related to trade and sanctions compliance.

• Manage compliance investigations across all functions coordinating with HR Quality and other stakeholders as appropriate.

• Develop and deliver targeted training programs addressing Code of Conduct ethics corporate compliance research compliance healthcare compliance and compliance topics such as export controls sanctions and trade compliance.

• Oversee compliance communications including the compliance hotline and escalation processes.

• Monitor coordinate and track day-to-day compliance activities enterprise-wide.

• Help build and manage a growing compliance team to support Revolution Medicines continued growth.

Regulatory Knowledge & External Engagement

• Maintain current working knowledge of laws regulations and guidance impacting the company including healthcare laws FDA and CMS regulations HIPAA FCPA data privacy laws DOJ and OIG guidance GxP requirements U.S. export control laws economic sanctions programs customs and tariff regulations and applicable international standards.

• Participate in and support government payer regulatory and internal audits and inspections including CMS FDA and state agency reviews and audits or inquiries related to trade compliance or international operations.

Required Skills Experience and Education:

• Juris Doctor (J.D.) degree from an accredited U.S. law school required; active U.S. bar membership preferred.

• 12 years of healthcare compliance experience in pharmaceuticals biotechnology or medical devices with in-house global healthcare experience strongly preferred.

• Experience in designing implementing and overseeing key elements of an effective compliance program including risk assessments monitoring and compliance technology systems.

• Knowledge of relevant legal and regulatory requirements including those related to consumer privacy data protection health information privacy (HIPAA) anti-kickback FDA Sunshine Act and PhRMA codes of ethics.

• Experience advising on corporate compliance matters beyond healthcare compliance including export controls sanctions trade compliance or other global regulatory requirements.

• Strong ability to assess complex compliance risks and develop practical business-friendly solutions that align with industry regulations and company objectives.

• Experience managing compliance investigations enforcement matters and advising senior executives and employees on a broad range of compliance and legal issues.

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

• Excellent leadership communication analytical and problem-solving skills with a proven track record in driving compliance initiatives.

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

• Team-oriented approach to work fostering a culture of development collaboration and ethical business practices.

• Managerial experience preferred as this role may manage one or more direct reports in the future to support the companys growth.

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