Manager, Biospecimen Operations, Translational Medicine
Confirmed live in the last 24 hours
Revolution Medicines
Compensation
$143,000 - $178,000/year
Job Description
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals 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.
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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.
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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.
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Oversee central lab activities, including operational lab startup, lab manual and site requisition form, SOW reviews and budget evaluation.
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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.
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Contribute to SOP development, operational process optimization, and biomarker program initiatives to support biomarker operation excellence.
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Support TM deliverables, including IA data reviews, CSR, and regulatory submissions for CDx filings.
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Drive vendor selection, qualification, onboarding, and participate in audits to ensure adherence to regulatory and quality standards.
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Provide biomarker operational metrics and study updates to cross‑functional teams and senior leadership to support strategic decision‑making
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Review ICFs and respond to EC and IRB inquiries related to biomarker components.
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Collaborate closely with Pharmacokinetic (PK) Leads to support PK operations and ensure timely delivery of all PK‑related clinical milestones.
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Bring experience in diagnostic operations supporting CDx development and regulatory filings, including sPMA submissions.
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Utilize IRT and EDC systems to enable real‑time sample tracking, data integration, and prompt query resolution.
Required Skills, Experience and Education:
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Life sciences degree (BS or MS) in scientific, medical, healthcare, or related discipline.
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7+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory.
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Should have experience mentoring team members.
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Prior experience in clinical biomarker and CDx operations in phase one to three clinical trials is strongly preferred.
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Prior experience in TruTech, SLOPE and LIMS platforms is highly desirable.
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Excellent scientific and business communication skills, strong interpersonal/collaboration skills, and planning skills.
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Should be proficient in Microsoft Excel, Microsoft PowerPoint applications.
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Experience in using Project Management tools is highly desired.
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Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
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Ability t
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