Late Phase Program Manager, Clinical Operations - Medical Affairs

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.

This is a unique opportunity for an experienced Clinical Operations professional with strong expertise in late‑phase clinical research and post‑marketing studies, and a solid understanding of clinical operations, Good Clinical Practice (GCP), and FDA regulatory requirements. Oncology experience is preferred.

• Serving as the Clinical Operations sponsor lead for Phase 4 and post‑marketing studies, including oversight of study start‑up, conduct, amendments, and close‑out activities following product approval.
• Providing oversight of vendor‑managed late‑phase trials and post‑marketing commitments, ensuring execution aligns with approved protocols, regulatory requirements, and contractual scope of work.
• Partnering with Regulatory, Medical Affairs, and Safety to support post‑marketing commitments, including alignment on timelines, milestone tracking, and regulatory deliverables.
• Supporting transition planning from development programs into post‑approval Phase 4 and post‑marketing research.

• Ensuring sponsor responsibilities under FDA regulations, ICH guidelines, and GCP are fulfilled for assigned programs.
• Reviewing vendor‑prepared regulatory communications and documentation, as applicable.
• Ensuring regulatory applications, amendments, notifications, and reports are submitted within required timelines.
• Overseeing Trial Master File (TMF) and essential documentation to ensure inspection readiness.
• Ensuring appropriate exchange of safety data and collaboration with Safety to meet pharmacovigilance obligations.
• Supporting inspection readiness and regulatory audit activities for assigned programs.

• Overseeing external vendors delivering late‑phase clinical services under executed Master Services Agreements and Work Orders.
• Monitoring vendor performance against scope, timelines, budget, and deliverables.
• Serving as the primary Clinical Operations point of contact between Revolution Medicines and vendors, ensuring clear communication, issue escalation, and resolution.
• Ensuring appropriate documentation of vendor oversight activities (e.g., Vendor Oversight Plans, Transfer of Responsibilities).

• Partnering with Supply Chain to support drug forecasting, availability, and shipment strategy for assigned studies.
• Ensuring appropriate documentation of drug accountability, returns, and reconciliation to support sponsor oversight.
• Reviewing and approving vendor invoices and tracking financial milestones in alignment with contracted scope of work.
• Supporting study close‑out activities, including financial reconciliation, documentation completeness, and vendor close‑out from a sponsor perspective.

• Tracking enrollment, study milestones, and operational risks; proactively identifying and escalating issues.
• Contributing to governance activities, metrics, dashboards, and process improvements for late‑phase and post‑marketing programs.
• Proactively identifying and resolving operational, regulatory, quality, or supply risks associated with late‑phase study execution.

• BS or MS degree with a minimum of 5–7 years of clinical operations experience in the pharmaceutical or biotech industry; oncology experience preferred.
• Direct experience supporting Phase 4, post‑marketing, or other late‑phase clinical research.
• Strong understanding of sponsor responsibilities under FDA regulations, ICH guidelines, and GCP.
• Demonstrated experience overseeing external vendors delivering…