Late Phase Senior Clinical Program Manager, Clinical Operations – Medical Affairs at Revolution Medicines

You're a seasoned Clinical Operations professional with at least 10 years of industry experience, holding a BS or MS, who has directly supported Phase 4 or post

Work type: hybrid

Location: Redwood City, California, United States

Salary: $164,000 – $205,000/yr

Type: Full-time

Summary

You're a seasoned Clinical Operations professional with at least 10 years of industry experience, holding a BS or MS, who has directly supported Phase 4 or post-marketing studies. You have a robust understanding of sponsor responsibilities under FDA regulations, ICH guidelines, and GCP. **What makes it worth a look...** Revolution Medicines is offering a full-time, hybrid role in Redwood City, California, with a salary of $164,000 - $205,000 annually. This position focuses on overseeing clinical operations for late-phase and post-marketing studies within a company developing novel targeted therapies for RAS-addicted cancers. **You might be a good fit if you...** * Have direct experience with Phase 4, post-marketing, or other late-phase clinical research. * Have demonstrated experience overseeing external vendors for regulated clinical programs. * Possess a strong understanding of FDA regulations, ICH guidelines, and GCP. * Have experience collaborating cross-functionally with Medical Affairs, Regulatory, and Safety.

Job Description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in 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 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.

• 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 10+ years of clinical operations experience in the pharmaceutical or biotech industry.

• 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 regulated clinical programs.

• Experience collaborating cross-functionally with Medical Affairs, Regulatory, Safety, Supply Chain, Quality, and Legal.

• Strong organizational, communication, and problem-solving skills.

• Demonstrated ability to manage multiple programs and priorities in a matrixed environment.

• Experience supporting global or multi-regional late-phase clinical studies.

• Familiarity with Quality Technical Agreements (QTAs), Safety Data Exchange Agreements (SDEAs), and vendor governance models.

• Experience supporting inspection readiness or regulatory audits related to late-phase or access programs.

• Oncology clinical research experience.

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.

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