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 Senior Specialist 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 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.
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 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.
Nice To Haves
- 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
501-1,000 employees
