[Hiring] Associate Director, Medical Affairs Governance @Revolution Medicines

Role Description

The Associate Director, Medical Affairs Governance will play a critical 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 expertise in global medical governance, compliance, and regulatory frameworks within the biotech/pharmaceutical industry.

Key Responsibilities

• Medical Governance & Compliance Leadership
  • 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.
• SOPs, Policies & Process Development
  • 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.
• 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 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.

Qualifications

• 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.

Preferred Skills

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

Benefits

• Competitive cash compensation.
• Robust equity awards.
• Strong benefits.
• Significant learning and development opportunities.

Company Description

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.