Senior Manager, Clinical Biomarker Operations

Revolution Medicines•Redwood City, CA

2d•$164,000 - $205,000•Hybrid

About The Position

Revolution Medicines is a global oncology company focused on discovering, developing, and delivering medicines for patients with RAS-addicted cancers. The Senior Manager, Clinical Biomarker Operations (CBO), within Translational Medicine, provides biomarker operations expertise and develops scopes of work while maintaining effective relationships with cross-functional teams supporting Phase I–III clinical trials. The role operationalizes biomarker program strategies for early- and late-stage development across the company’s portfolio. The position leads end-to-end biomarker operations across oncology trials, including protocol reviews, prospective testing strategies, sample lifecycle oversight, data management, query resolution, and vendor qualification and contracting. It works with biomarker, bioinformatics, and companion diagnostic scientists and partners to align operational documents, testing strategies, sample handling, data transfers, and study delivery. The role also oversees central and specialty laboratory operations, vendor performance, budgets, timelines, quality, and regulatory compliance. The Senior Manager collaborates broadly across Clinical Development, Clinical Operations, Data Management, Quality Assurance, Regulatory Affairs, Procurement, Biospecimen Management, and external partners. The position supports Translational Medicine deliverables and regulatory submissions, manages and mentors junior CBO Leads, and serves as a subject matter expert for biomarker processes, SOP development, and operational improvements. It provides study metrics and updates to cross-functional teams and senior leadership.

Requirements

MS or PhD in life sciences or a related scientific, medical, or healthcare discipline.
10+ years of project management and/or related professional experience in a clinical research setting or clinical/diagnostic laboratories.
Experience managing and mentoring team members.
Proven leadership and people-management ability, including fostering a collaborative, productive, and cohesive environment.
Excellent scientific and business communication skills, interpersonal and collaboration skills, and planning skills.
Strong attention to detail, organizational skills, and time-management skills.
Ability to think critically and creatively, work independently, and identify appropriate resources to resolve problems.
Ability to multitask, adapt, and thrive in a fast-paced, innovative environment with changing priorities.
Collaborative approach, including listening effectively and inviting responses and discussion.
Proficiency with Microsoft Office applications, including Word, Excel, Project, and PowerPoint.
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 clinical biomarker and CDx operations across Phase I–III oncology trials, including diagnostic operations supporting CDx development and regulatory filings.
Experience using project management tools beyond Microsoft Office.
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.

Responsibilities

Operationalize biomarker program strategies in clinical trials supporting early- and late-stage development.
Lead end-to-end biomarker operations across Phase I–III oncology trials, including protocol reviews, prospective testing strategies, sample lifecycle oversight, data management, query resolution, and vendor qualification and contracting.
Collaborate with biomarker, bioinformatics, and companion diagnostic scientists on protocols, informed consent forms, eCRFs, data transfer specifications, Genomic Verification Forms, and eTMF documentation.
Work with biomarker scientists to oversee statements of work, budgets, timelines, risk management, and vendor management across active studies.
Contribute to central laboratory operations, including laboratory startup and review of laboratory manuals, site requisition forms, scopes of work, and budgets.
Coordinate cross-functionally to ensure operational feasibility and delivery aligned with clinical trial timelines.
Collaborate with diagnostic partners and internal teams to manage companion diagnostic samples.
Lead biomarker vendor selection, qualification, onboarding, and oversight; participate in vendor audits and manage vendor delivery against contracted scopes of work.
Work with Clinical Operations and Biospecimen Management to manage sample shipment, storage, and destruction, as applicable.
Oversee specialty biomarker laboratory relationships, sample logistics, testing strategy alignment, 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 IRT and EDC systems, when applicable.
Ensure study adherence to ICH GCP guidelines, SOPs, best practices, and ethical guidelines.
Oversee biomarker-related EC/IRB inquiries and ensure accurate, 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 overseeing early- and late-stage trials and CROs.
Serve as a subject matter expert and process owner for biomarker-related CBO processes; lead SOP development and operational process optimization.
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 decisions, identify risks, and guide corrective actions.