Clinical Biomarker Operations Manager

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Opportunity:

Playing a critical role as a Manager, Biospecimen Operations within Translational Medicine function, the position will be providing biomarker operational expertise in, developing scope of work, and maintaining effective working relationships with cross-functional teams for phase three clinical trials.

• Lead end‑to‑end biomarker operations across Phase I–III oncology clinical trials, including protocol reviews, prospective testing strategies, sample lifecycle oversight, data management, query resolution, and vendor qualification and contracting.

• Collaborate cross‑functionally with Biomarker Leads, Companion Diagnostics, Clinical Operations, and Data Management on reviews of protocol, ICF, eCRF, DTS, Genomic Verification Forms, and eTMF documentation to ensure operational alignment.

• Oversee central lab activities, including operational lab startup, lab manual and site requisition form, SOW reviews and budget evaluation.

• Manage relationships with specialty biomarker labs, including sample logistics oversight, testing strategy alignment, RUO data transfer execution, issue and query resolution, invoice review, and coordination of recurring operational meetings.

• Contribute to SOP development, operational process optimization, and biomarker program initiatives to support biomarker operation excellence.

• Support TM deliverables, including IA data reviews, CSR, and regulatory submissions for CDx filings.

• Drive vendor selection, qualification, onboarding, and participate in audits to ensure adherence to regulatory and quality standards.

• Provide biomarker operational metrics and study updates to cross‑functional teams and senior leadership to support strategic decision‑making.

• Review ICFs and respond to EC and IRB inquiries related to biomarker components.

• Bring experience in diagnostic operations supporting CDx development and regulatory filings, including sPMA submissions.