Director, Medical Affairs Governance

Redwood City, CA - USA

Monthly Salary: Not Disclosed

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Job Summary

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 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.

Key responsibilities include:

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.

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.
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.
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The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role level and location. Individual base pay salary is determined by multiple factors including job-related skills experience market dynamics and relevant education or training.

Please note that base pay salary range 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 ourCCPA additional information please contact .

Base Pay Salary Range

$211000$264000 USD

Required Experience:

Director