Manager, Clinical Biomarker Operations

Revolution Medicines, Inc.

San Francisco (CA)

On-site

USD 143,000 - 178,000

Full time

9 days ago

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Benefits offered by this job

Equity awards
Learning opportunities
Strong benefits
Onsite Redwood City

Job summary

Revolution Medicines is seeking a Manager, Biospecimen Operations within Translational Medicine to provide biomarker operational expertise for Phase I–III oncology trials. You will lead end‑to‑end biomarker operations, coordinate with cross‑functional teams, and drive SOPs and vendor efforts to ensure quality and regulatory alignment.

The role requires a Life Sciences degree with 7+ years in clinical research or clinical diagnostics, mentoring experience, and strong skills in Excel/PowerPoint.

Qualifications

  • Life sciences degree (BS or MS).
  • 7+ years in a clinical research setting or clinical/diagnostic laboratory.
  • Experience mentoring team members.
  • Prior experience in biomarker and CDx operations in phase I–III trials is preferred.
  • Experience with TruTech, SLOPE and LIMS platforms is desirable.
  • Excellent science and business communication, collaboration and planning skills.
  • Proficient in Excel and PowerPoint.

Responsibilities

  • Lead end‑to‑end biomarker operations across Phase I–III oncology trials, including protocol reviews, testing strategies, sample lifecycle oversight, data management, and vendor contracting.
  • Collaborate with Biomarker Leads, CDx, Clinical Operations, and Data Management on protocol, ICF, eCRF, DTS, Genomic Verification Forms, and eTMF documentation.
  • Oversee central lab activities, including startup, lab manual, site requisition forms, SOW reviews, and budget evaluation.
  • Manage relationships with specialty biomarker labs, including sample logistics, testing strategy alignment, RUO data transfer, issue resolution, invoicing, and recurring meetings.
  • Contribute to SOP development, process optimization, and biomarker program initiatives for operation excellence.
  • Support TM deliverables such as IA data reviews, CSR, and regulatory submissions for CDx filings.
  • Drive vendor selection, qualification, onboarding, and participate in audits to ensure regulatory and quality standards.
  • Provide biomarker operational metrics and study updates to cross‑functional teams and leadership.
  • Review ICFs and respond to EC/IRB inquiries related to biomarker components.
  • Utilize IRT and EDC systems to enable real‑time sample tracking and data integration.

Skills

Mentoring
Cross-functional collaboration
Biomarker operations
CDx knowledge
Problem solving
Critical thinking
Team player

Education

Life sciences degree (BS or MS)

Tools

Microsoft Excel
Microsoft PowerPoint
LIMS platforms
Project management tools

Job description

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.
  • 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.

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

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