Senior Manager, Clinical Biomarker Operations

The Opportunity:

As a Senior Manager, Clinical Biomarker Operations (CBO) within the Translational Medicine function, you will provide biomarker operational expertise, develop scope of work (SOW), and maintain effective working relationships with cross-functional teams supporting Phase I–III clinical trials.

• 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

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