Externally Sponsored Research (ESR), Clinical Operations Manager

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:

This is a unique opportunity for an experienced Clinical Operations professional with strong expertise in Medical Affairsowned Externally Sponsored Research (ESR) and a solid understanding of clinical operations Good Clinical Practice (GCP) and U.S. Food and Drug Administration (FDA) regulatory requirements. Oncology experience is preferred.

As the Clinical Operations Manager Medical Affairs ESR Program reporting to the Director Clinical Operations Medical Affairs you will be responsible for Clinical Operations oversight of ESR studies following approval from protocol development through study close-out. This role serves as the primary Clinical Operations owner for ESR execution ensuring compliant study activation ongoing oversight and documentation of sponsor responsibilities in alignment with internal SOPs and regulatory expectations.

Specifically you will be responsible for:

• Clinical Operations functional activities related to the execution of Medical Affairsowned ESR studies following approval in alignment with department and corporate objectives.

• Acting as the Clinical Operations owner for ESR studies from protocol approval through final study close-out including activation conduct and oversight activities.

• Coordinating the Clinical Operations start-up process for approved ESR studies.

• Oversight of contracting activities in collaboration with Clinical Site Contracts including QC and routing budgets for Fair Market Value (FMV) review supporting contract negotiations applying study-specific milestones to contracts and ensuring contract and budget amendments are executed.

• Serving as the primary Clinical Operations point of contact for ESR sponsors and sites once studies are approved.

• Supporting Regulatory Affairs by providing lists of ESR studies and participating countries requesting and managing IND Right of Reference (RoR) letters and tracking regulatory approvals.

• Ensuring readiness for site activation by confirming receipt and review of essential documents (e.g. IRB approvals regulatory approvals clinical trial registrations).

• Coordinating drug supply activities for all ESRs throughout the lifecycle of the ESR.

• Oversight of Trial Master File (TMF) documentation to ensure appropriate documentation of sponsor oversight throughout the study lifecycle.

• Tracking enrollment milestone progress and study status

• Ensuring enrollment logs and exposure data are provided to Regulatory and Safety to support DSURs PBRERs and other safety reporting.

• Review and approval of ESR invoices tied to milestone completion and reconciliation of payments.

• Partnering with Medical Science Liaisons (MSLs) on milestone tracking of enrollment and publication timing as well as Clinical Operations trial insights.

• Managing study close-out activities including drug accountability reconciliation financial reconciliation TMF completeness and contract closure documentation.

• Participation in cross-functional team meetings and proactive identification escalation and resolution of operational issues.

Required Skills Experience and Education:

• BS or MS degree with a minimum of 57 years of clinical operations experience in the pharmaceutical or biotech industry; oncology experience preferred.

• Direct experience supporting Externally Sponsored Research (ESR) Investigator-Sponsored Trials (ISTs) or Medical Affairsled research.

• Strong working knowledge of FDA regulations ICH guidelines and GCP governing the conduct of clinical research.

• Experience with clinical trial budgets FMV principles contract amendments and invoice review.

• Demonstrated ability to manage multiple studies and priorities in a matrixed cross-functional environment.

• Excellent written and verbal communication skills.

• Demonstrated ability to anticipate operational risks escalate issues appropriately and execute with minimal oversight.

Preferred Skills:

• Oncology clinical research experience.

• Global clinical research experience.

• Experience working closely with Medical Affairs and Field Medical teams.

• Familiarity with TMF systems clinical trial tracking tools and cross-functional governance models.

• Experience supporting regulatory submissions and safety reporting activities.

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