Manager, Clinical Biomarker Operations

Revolution Medicines•Redwood City, CA

6d•Hybrid

About The Position

Revolution Medicines is a global, commercial-stage oncology company dedicated to discovering, developing, and delivering innovative medicines for patients with RAS-addicted cancers. Playing a critical role as a Manager, Biospecimen Operations within the Translational Medicine function, this position will provide biomarker operational expertise, develop scope of work, and maintain effective working relationships with cross-functional teams for phase three clinical trials. The role involves leading 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. Collaboration with Biomarker Leads, Companion Diagnostics, Clinical Operations, and Data Management is key for reviewing protocol, ICF, eCRF, DTS, Genomic Verification Forms, and eTMF documentation to ensure operational alignment. The position also oversees central lab activities, manages relationships with specialty biomarker labs, and contributes to SOP development and process optimization to support biomarker operation excellence. Support for TM deliverables, including IA data reviews, CSR, and regulatory submissions for CDx filings, is also expected. Driving vendor selection, qualification, onboarding, and participating in audits are crucial. Providing biomarker operational metrics and study updates to cross-functional teams and senior leadership is essential for strategic decision-making. Reviewing ICFs and responding to EC and IRB inquiries related to biomarker components is part of the role. Experience in diagnostic operations supporting CDx development and regulatory filings, including sPMA submissions, is required. Utilizing IRT and EDC systems for real-time sample tracking, data integration, and prompt query resolution is necessary.

Requirements

Life sciences degree (BS or MS) in scientific, medical, healthcare, or related discipline.
7+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory.
Experience mentoring team members.
Prior experience in clinical biomarker and CDx operations in phase one to three clinical trials is strongly preferred.
Excellent scientific and business communication skills.
Strong interpersonal/collaboration skills.
Strong planning skills.
Proficient in Microsoft Excel, Microsoft PowerPoint applications.
Ability to think critically and creatively.
Ability to work independently to determine appropriate resources for resolution of problems.
Ability to multi-task and thrive in a fast-paced innovative environment.
A great teammate, who listens effectively and invites response and discussion.
Commitment to Revolution Medicines’ Core Values: Tireless Commitment to Patients, Transformative Science, Exceptional Together, Total Integrity, Inclusiveness and Fairness.

Nice To Haves

Prior experience in TruTech, SLOPE and LIMS platforms is highly desirable.
Experience in using Project Management tools is highly desired.
Experience in using LIMS Sample Management tool is desirable.
Experience with next-generation sequencing (NGS) methods for RAS mutation analysis is desirable.

Responsibilities

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.
Utilize IRT and EDC systems to enable real‑time sample tracking, data integration, and prompt query resolution.