Manager, Biospecimen Operations, Translational Medicine

Revolution Medicines•Redwood City, CA

11h•Onsite

About The Position

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. 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. Collaborate closely with Pharmacokinetic (PK) Leads to support PK operations and ensure timely delivery of all PK‑related clinical milestones. 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.

Requirements

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.
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.

Nice To Haves

Prior experience in TruTech, SLOPE and LIMS platforms is highly desirable.
Experience in using LIMS Sample Management tool is desirable.
Experience with next-generation sequencing (NGS) methods for RAS mutation analysis is desirable.

Responsibilities

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.
Collaborate closely with Pharmacokinetic (PK) Leads to support PK operations and ensure timely delivery of all PK‑related clinical milestones.
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.