Manager, Clinical Biomarker Operations
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.
Utilize IRT and EDC systems to enable real‑time 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.
#LI-EM1 #LI-Hybrid
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.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
Base Pay Salary Range
$143,000—$178,000 USD