Director, Medical Affairs Governance

Revolution Medicines•Redwood City, CA

39d•Remote

About The Position

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s 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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Director, Medical Affairs Governance will play a critical leadership role in ensuring robust governance, compliance, and operational excellence across all Medical Affairs functions, assets, and regions. This role will establish and oversee global governance frameworks, including Medical Review Committees (MRCs), SOPs, inspection readiness, and cross-functional medical governance initiatives. The ideal candidate will have deep expertise in global medical governance, compliance, and regulatory frameworks within the biotech/pharmaceutical industry.

Requirements

Advanced scientific or medical degree (PhD, PharmD, MD) preferred; MS or equivalent experience in biomedical sciences or related field considered.
10+ years of experience in Medical Affairs or related functions within the biotechnology, pharmaceutical, or healthcare industry.
Strong background in Medical Governance, Compliance, Regulatory Affairs, or Medical Operations.
Experience working in global biotech/pharmaceutical environments, supporting multiple regions and therapeutic areas.
Deep knowledge of global regulatory requirements for Medical Affairs, including FDA, EMA, ICH, GVP, and industry best practices.
Proven experience developing SOPs, policies, and governance frameworks to support medical organizations.
Strong track record in inspection readiness, audits, and compliance oversight for Medical Affairs functions.
Ability to navigate complex regulatory and legal environments and advise teams on governance best practices.
Experience leading Medical Review Committees (MRCs) or similar governance structures.
Strong interpersonal, communication, and leadership skills with the ability to influence cross-functional stakeholders.

Nice To Haves

Prior experience in oncology, precision medicine, or targeted therapies.
Expertise in digital platforms for compliance tracking, document management, and governance reporting.

Responsibilities

Develop and implement a comprehensive global Medical Governance framework to support strategic and operational excellence across Medical Affairs.
Lead governance process for Medical Affairs, including facilitation and coordination of the Medical Project Review Group.
Lead governance for all Medical Affairs functions, including medical information, medical education, scientific engagement, congress strategy, and publications.
Partner with cross-functional teams (Legal, Compliance, Regulatory) to ensure adherence to industry standards, company policies, and regulatory requirements.
Oversee the medical review responsibilities and process for Medical Legal Review committees, ensuring efficient and compliant medical review of materials, communications, and scientific content.
Ensure medical activities align with corporate policies and external regulatory guidance, including FDA, EMA, PhRMA Code, ICH, GVP, and other relevant regulations.
Establish, maintain, and optimize global Medical Affairs Standard Operating Procedures (SOPs), Work Instructions, and best practices to drive consistency and compliance.
Conduct periodic reviews of policies and ensure Medical Affairs teams are trained on key processes.
Partner with Compliance on SOP initiatives.
Drive continuous improvement efforts to streamline governance frameworks and enhance efficiency within Medical Affairs operations.
Lead inspection readiness efforts across Medical Affairs, ensuring processes, documentation, and governance frameworks meet regulatory expectations.
Act as a point of contact for regulatory inspections and internal audits, providing oversight and guidance on Medical Affairs-related compliance activities.
Collaborate with QA and Compliance to identify risks, implement corrective and preventive actions (CAPAs), and maintain audit readiness.
Work across therapeutic areas, geographies, and functions to ensure seamless integration of governance processes within the global Medical Affairs organization.
Provide strategic guidance to Medical Affairs leadership on governance best practices and risk mitigation strategies.
Act as the key liaison between Medical Affairs, Compliance, Legal, and other internal stakeholders to align governance initiatives across the organization.