What are the responsibilities and job description for the Director, Medical Affairs Governance position at Revolution Medicines?
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 professionals 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. Reporting to the Head of Medical Excellence, this role will establish and oversee governance frameworks, including Medical Review Committees (MRCs), SOPs, inspection readiness, and cross-functional medical governance initiatives. The ideal candidate will have deep expertise in medical governance, compliance, and regulatory frameworks within the biotech/pharmaceutical industry.
Key responsibilities include:
Medical Governance & Compliance Leadership
Develop and implement a comprehensive Medical Governance framework to support strategic and operational excellence across Medical Affairs.
Lead governance process for the 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, publications, and field medical teams.
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.
SOPs, Policies & Process Development
Establish, maintain, and optimize 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.
Drive continuous improvement efforts to streamline governance frameworks and enhance efficiency within Medical Affairs operations.
Inspection Readiness & Audit Support
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.
Cross-Functional Collaboration & Global Medical Governance
Work across therapeutic areas, geographies, and functions to ensure seamless integration of governance processes within the 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.
Required Skills, Experience and Education:
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.
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.
Preferred Skills:
Prior experience in oncology, precision medicine, or targeted therapies.
Experience working in global biotech/pharmaceutical environments, supporting multiple regions and therapeutic areas.
Proven ability to build governance frameworks from the ground up in high-growth or emerging biotech organizations.
Expertise in digital platforms for compliance tracking, document management, and governance reporting.
The base salary range for this full-time position is $204,000 to $255,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
#LI-Hybrid #LI-YG1
Salary : $204,000 - $255,000
