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Late Phase Program Manager, Clinical Operations – Medical Affairs
About the position
- 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.
- As the Medical Affairs Late Phase Program Manager, reporting to the Director, Clinical Operations – Medical Affairs, you will be responsible for Clinical Operations oversight of Medical Affairs–owned late-phase and post-marketing clinical research activities.
- This role serves as the primary Clinical Operations sponsor representative for assigned Phase 4 and post-marketing studies. You will be accountable for vendor oversight, regulatory alignment, drug supply governance, safety and quality oversight, financial stewardship, and inspection readiness, while operational execution is performed by external service providers under approved Statements of Work.
- Specifically, you will be responsible for:
- Late-Phase & Post-Marketing Oversight.
- 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.
- Sponsor Governance & Compliance
- 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.
- Vendor Oversight & Operational Execution
- 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).
- Drug Supply & Financial Oversight
- 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.
- Risk Management & Continuous Improvement
- 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.
- Responsibilities
- 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, a
