Manager, Biospecimen Operations, Translational Medicine

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.

Required Skills, Experience and Education:

• 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.

• Prior experience in TruTech, SLOPE and LIMS platforms 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 Skills:

• 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. 

  #LI-Hybrid  #LI-SH1