Senior Manager, Clinical Biomarker Operations

Revolution Medicines, Inc.; Redwood City (CA); On-site; USD 164,000 - 205,000; Full time

Job summary

Revolution Medicines is seeking a senior biomarker operations leader to manage end-to-end biomarker programs across oncology trials. You will oversee protocol reviews, prospective testing strategies, and vendor management while ensuring data integrity and regulatory compliance.

The role requires extensive experience in clinical biomarker/CDx operations, with strong leadership and cross-functional collaboration to enable timely study delivery in a fast-paced environment.

Qualifications

• MS or PhD in life sciences or related field.
• 10+ years of experience in project management and/or clinical research.
• Experience leading and mentoring teams.
• Proven leadership and collaboration across cross-functional teams.
• Experience in clinical biomarker/CDx operations across Phases I–III oncology trials.

Responsibilities

• Operationalize biomarker program strategies in clinical trials across Phases I–III.
• Lead end-to-end biomarker operations including protocol reviews, testing strategies, sample lifecycle oversight, data management and vendor contracting.
• Collaborate with biomarker, bioinformatics, and CDx scientists to ensure operational alignment and successful sample collection/testing.
• Oversee SOW development, budgets, timelines, risk management and vendor management across active studies.
• Ensure adherence to ICH-GCP, SOPs, and regulatory requirements.

Skills

Project management

Leadership

Cross-functional collaboration

Scientific communication

Independent thinking

Mentoring

Education

MS or PhD in life sciences

Tools

LIMS

TruTech

SLOPE

NGS methods

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:

• Operationalize the biomarker program strategies in clinical trials to support early- and late-stage development of portfolio assets.
• 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 effectively with biomarker, bioinformatics, and companion diagnostic (CDx) scientists on reviews of protocols, informed consent forms (ICFs), electronic case report forms (eCRFs), data transfer specifications (DTS), Genomic Verification Forms, and electronic trial master file (eTMF) documentation to ensure operational alignment and successful collection and testing of clinical trial samples.
• Work closely with biomarker scientists to oversee the development of the statement of work (SOW), budgets, timelines, risk management, and vendor management across all active studies.
• Contribute to central laboratory operations, including laboratory startup, review of laboratory manuals and site requisition forms, SOW review, and budget evaluation.
• Collaborate cross-functionally with Clinical Development, Clinical Operations, Data Management, Quality Assurance, Regulatory Affairs, Procurement, etc., to ensure operational feasibility and delivery, aligned with clinical trial timelines.
• Collaborate with diagnostic partners and internal cross-functional team members to ensure successful management of CDx samples.
• Lead biomarker vendor selection, qualification, onboarding, and oversight; participate in vendor audits to assess adherence to regulatory and quality standards; and provide day-to-day operational management to ensure delivery against the contracted SOW.
• Collaborate with Clinical Operations and the Biospecimen Management group to manage sample shipment, sample storage, and sample destruction, as applicable.
• Oversee specialty biomarker laboratory relationships, including sample logistics, alignment of testing strategies, execution of research use only (RUO) data transfers, issue and query resolution, invoice review, and recurring operational meetings.
• Support real-time sample tracking, data integration, and timely query resolution using interactive response technology (IRT) and electronic data capture (EDC) systems, when applicable.
• Ensure study adherence to the International Council for Harmonization (ICH) Good Clinical Practice (GCP) guidelines, standard operating procedures (SOPs), best practices, and ethical guidelines.
• Oversee biomarker-related ethics committee/institutional review board (EC/IRB) inquiries to ensure accurate and consistent responses across studies.
• Support Translational Medicine deliverables, including data reviews, clinical study reports, audits, and regulatory submissions for CDx filings.
• Manage and mentor junior CBO Leads responsible for early- and late-stage clinical trials and day-to-day oversight of contract research organizations (CROs), ensuring timely, high-quality delivery.
• Serve as a subject matter expert and owner for one or more biomarker-related processes within the CBO sub-function, lead SOP development and operational process optimization, and contribute to biomarker program initiatives that improve operational quality and efficiency.
• Provide biomarker operational metrics and study updates to cross-functional teams and senior leadership to inform strategic decisions, identify risks, and guide corrective actions.

Required Skills, Experience and Education:

• MS or PhD in life sciences or a related scientific, medical, or healthcare discipline.
• 10+ years of experience in project management and/or related professional experience in a clinical research setting, or clinical/diagnostic laboratories.
• Experience managing and mentoring team members.
• Proven track record of effective leadership and people management, creating a collaborative environment that fosters productivity and cohesiveness.
• Prior experience in clinical biomarker and CDx operations across Phase I–III oncology clinical trials, including diagnostic operations supporting CDx development and regulatory filings, is strongly preferred.
• Excellent scientific and business communication skills, strong interpersonal and collaboration skills, and effective planning skills.
• Strong attention to detail, great organizational skills, and time management skills.
• Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
• Ability to multitask, adapt, and thrive in a fast-paced, innovative environment with changing priorities.
• A collaborative teammate who listens effectively and invites responses and discussion.
• Proficient in Microsoft Office applications, including Word, Excel, Project, and PowerPoint.
• Experience in using other project management tools is highly desirable.
• Commitment to Revolution Medicines’ Core Values: Tireless Commitment to Patients, Transformative Science, Exceptional Together, Total Integrity, Inclusiveness and Fairness.

Preferred Skills:

• Project Management Professional (PMP) certification.
• Experience with TruTech, SLOPE, and laboratory information management systems (LIMS) for sample management
• Experience with next-generation sequencing (NGS) methods for RAS mutation analysis

#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 [e-mail].

Base Pay Salary Range

$164,000—$205,000 USD