Manager, Biospecimen Operations, Translational Medicine jobs in United States
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Revolution Medicines · 1 day ago

Manager, Biospecimen Operations, Translational Medicine

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The Manager of Biospecimen Operations will provide biomarker operational expertise, oversee clinical study operations, and manage relationships with various labs to support phase three clinical trials.

Health CareLife ScienceMedical
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H1B Sponsor Likelynote

Responsibilities

Lead biomarker operations across clinical studies, including protocol planning, testing strategy, data management, and documentation
Collaborate with Biomarker Leads and Clinical Operations on protocol, ICF, eCRF, and eTMF reviews
Oversee central lab activities: budget and SOW reviews, lab manual and site requisition form reviews
Partner with CQA for initiating new vendor qualification to conducting biomarker testing
Manage relationships with central/specialty labs and Biobank, initiate study contracts, coordinate meeting discussions, review invoices, and issue resolutions
Develop and maintain tracking systems for sample logistics and data generation
Contribute to SOP development and biomarker program initiatives
Support TM deliverables including interim analyses, CSRs, and regulatory filings
Help manage biomarker operations budgets, identify and mitigate sample/data handling risks
Independently lead biomarker operations for Phase III oncology trials
Oversee vendor selection and participate in audits
Engage cross-functional teams and provide Biomarker metrics and updates
Responsible for reviewing ICFs and addressing inquiries from ECs and/or IRBs related to Biomarker components
Collaborate closely with Pharmacokinetic leads to support PK operations and ensure all PK deliverables are met according to project requirements
Experience in diagnostic operations supporting CDx and sPMA regulatory filing
Utilize IRT systems and present biomarker strategies to senior leadership

Qualification

Clinical research experienceBiomarker operationsCDx operationsProject Management toolsNext-generation sequencingMicrosoft ExcelMicrosoft PowerPointInterpersonal skillsCommunication skillsMentoringCritical thinkingTeamwork

Required

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 three clinical trials is highly desirable
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

Preferred

Should be proficient in Microsoft Excel, Microsoft PowerPoint applications
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

Benefits

Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities

Company

Revolution Medicines

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Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.

H1B Sponsorship

Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$2.25B
Key Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M

Leadership Team

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Luan Wilfong
Chief Human Resources Officer
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Steve Kelsey
President
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Company data provided by crunchbase