Manager, Biospecimen Operations, Translational Medicine
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.
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.
- 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 Project Management tools is 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
