Manager, Clinical Biomarker Operations

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 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 rigorall 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 endtoend biomarker operations across Phase IIII oncology clinical trials including protocol reviews prospective testing strategies sample lifecycle oversight data management query resolution and vendor qualification and contracting.

• Collaborate crossfunctionally 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 crossfunctional teams and senior leadership to support strategic decisionmaking.

• 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 realtime sample tracking data integration and prompt query resolution.

Required Skills Experience and Education:

• 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.

• Should have experience mentoring team members.

• Prior experience in clinical biomarker and CDx operations in phase one to three clinical trials is strongly preferred.

• Prior experience in TruTech SLOPE and LIMS platforms is highly desirable.

• Excellent scientific and business communication skills strong interpersonal/collaboration skills and planning skills.

• Should be proficient in Microsoft Excel Microsoft PowerPoint applications.

• Experience in using Project Management tools is highly desired.

• Ability to think critically and creatively and be able 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.

Preferred Skills:

• Should be proficient in Microsoft Excel Microsoft PowerPoint applications.

• Experience in using Project Management tools is desirable.

• Experience in using LIMS Sample Management tool is desirable.

• Experience with next-generation sequencing (NGS) methods for RAS mutation analysis is desirable.

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