About the job
Revolution Medicines is a pioneering clinical-stage precision oncology firm dedicated to developing innovative targeted therapies aimed at inhibiting critical targets in RAS-addicted cancers. Our robust R&D pipeline features RAS(ON) Inhibitors designed to suppress various oncogenic variants of RAS proteins, along with RAS Companion Inhibitors that enhance combination treatment strategies. By joining Revolution Medicines, you will become part of a passionate team committed to improving the lives of patients battling cancers linked to mutations in the RAS signaling pathway.
About the Role:
This position offers a unique opportunity for a seasoned Clinical Operations expert with extensive experience in Medical Affairs-led Externally Sponsored Research (ESR) and a strong grasp of clinical operations, Good Clinical Practice (GCP), and U.S. Food and Drug Administration (FDA) regulations. Experience in oncology is preferred.
As the Senior Manager of Clinical Operations for the Medical Affairs ESR Program, reporting directly to the Director of Clinical Operations – Medical Affairs, you will oversee all Clinical Operations activities for ESR studies post-approval, managing everything from protocol development to study close-out. You will be the primary clinical operations lead for ESR execution, ensuring compliant study initiation, continuous oversight, and thorough documentation of sponsor responsibilities in line with internal SOPs and regulatory standards.
Your key responsibilities will include:
- Managing Clinical Operations activities related to the execution of Medical Affairs-owned ESR studies post-approval, ensuring alignment with departmental and corporate goals.
- Acting as the Clinical Operations lead for ESR studies from protocol approval through to final study close-out, including study activation, conduct, and oversight.
- Coordinating the start-up process for approved ESR studies within Clinical Operations.
- Overseeing contracting processes in partnership with Clinical Site Contracts, ensuring quality control and budget routing for Fair Market Value (FMV) reviews, supporting contract negotiations, and handling study-specific milestones and amendments.
- Serving as the main Clinical Operations liaison for ESR sponsors and sites once studies are approved.
- Assisting Regulatory Affairs by providing details of ESR studies and participating countries, managing IND Right of Reference (RoR) letters, and tracking regulatory approvals.
- Ensuring site readiness for activation by confirming all necessary requirements are fulfilled.