Senior Manager, Clinical Biomarker Operations

Revolution Medicines•Redwood City, CA

1d•Onsite

About The Position

Revolution Medicines is seeking a Senior Manager, Clinical Biomarker Operations (CBO) within its Translational Medicine function. The role provides biomarker operational expertise and operationalizes biomarker program strategies across Phase I–III oncology clinical trials, supporting early- and late-stage development of the company’s portfolio. The Senior Manager leads end-to-end biomarker operations, including protocol reviews, prospective testing strategies, sample lifecycle oversight, data management, query resolution, and vendor qualification and contracting. The position collaborates with biomarker, bioinformatics, companion diagnostic (CDx), clinical, and other cross-functional teams to align operational plans and support successful collection and testing of trial samples. It oversees statements of work, budgets, timelines, risk management, vendors, central laboratory operations, sample logistics, and data transfers. The role also supports study deliverables, regulatory submissions for CDx filings, and compliance with applicable quality, regulatory, ethical, and clinical practice requirements. The Senior Manager manages and mentors junior CBO Leads, serves as a subject matter expert for biomarker-related processes, leads SOP development and process optimization, and provides operational metrics and study updates to teams and senior leadership. The position is based onsite at Revolution Medicines’ headquarters in Redwood City, California, with a base salary range of $164,000–$205,000 for onsite candidates; the range is adjusted for local market.

Requirements

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 leadership and people-management skills, including creating a collaborative environment that fosters productivity and cohesiveness.
Excellent scientific and business communication skills; strong interpersonal, collaboration, and planning skills.
Strong attention to detail, organizational skills, and time-management skills.
Ability to think critically and creatively, work independently, and determine 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 in 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 clinical trials, including diagnostic operations supporting CDx development and regulatory filings.
Experience using other project management tools.
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 across Phase I–III clinical trials in support of early- and late-stage development.
Lead end-to-end biomarker operations, including protocol reviews, prospective testing strategies, sample lifecycle oversight, data management, query resolution, and vendor qualification and contracting.
Collaborate with biomarker, bioinformatics, and CDx scientists to review protocols, informed consent forms, eCRFs, data transfer specifications, Genomic Verification Forms, and eTMF documentation.
Work with biomarker scientists to oversee SOW development, 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, SOWs, and budgets.
Collaborate with Clinical Development, Clinical Operations, Data Management, Quality Assurance, Regulatory Affairs, Procurement, and other teams to ensure operational feasibility and delivery aligned with trial timelines.
Work with diagnostic partners and internal teams to manage CDx samples.
Lead biomarker vendor selection, qualification, onboarding, and oversight; participate in vendor audits; and provide day-to-day operational management against contracted SOWs.
Work with Clinical Operations and Biospecimen Management to manage sample shipment, storage, and destruction, as applicable.
Oversee specialty biomarker laboratory relationships, including 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, ensuring timely, high-quality delivery.
Serve as a subject matter expert and process owner for biomarker-related CBO processes; lead SOP development and operational process optimization; and contribute to 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.