Biomarker Operations Manager, Phase I–III Oncology

Revolution Medicines, Inc.; San Francisco (CA); Vor Ort; USD 143.000 - 178.000; Vollzeit

Benefits dieser Stelle

Equity awards

Learning opportunities

Strong benefits

Onsite Redwood City

Zusammenfassung

Revolution Medicines is seeking a Manager, Biospecimen Operations within Translational Medicine to provide biomarker operational expertise for Phase I–III oncology trials. You will lead end‑to‑end biomarker operations, coordinate with cross‑functional teams, and drive SOPs and vendor efforts to ensure quality and regulatory alignment.

The role requires a Life Sciences degree with 7+ years in clinical research or clinical diagnostics, mentoring experience, and strong skills in Excel/PowerPoint.

Qualifikationen

• Life sciences degree (BS or MS).
• 7+ years in a clinical research setting or clinical/diagnostic laboratory.
• Experience mentoring team members.
• Prior experience in biomarker and CDx operations in phase I–III trials is preferred.
• Experience with TruTech, SLOPE and LIMS platforms is desirable.
• Excellent science and business communication, collaboration and planning skills.
• Proficient in Excel and PowerPoint.

Aufgaben

• Lead end‑to‑end biomarker operations across Phase I–III oncology trials, including protocol reviews, testing strategies, sample lifecycle oversight, data management, and vendor contracting.
• Collaborate with Biomarker Leads, CDx, Clinical Operations, and Data Management on protocol, ICF, eCRF, DTS, Genomic Verification Forms, and eTMF documentation.
• Oversee central lab activities, including startup, lab manual, site requisition forms, SOW reviews, and budget evaluation.
• Manage relationships with specialty biomarker labs, including sample logistics, testing strategy alignment, RUO data transfer, issue resolution, invoicing, and recurring meetings.
• Contribute to SOP development, process optimization, and biomarker program initiatives for operation excellence.
• Support TM deliverables such as IA data reviews, CSR, and regulatory submissions for CDx filings.
• Drive vendor selection, qualification, onboarding, and participate in audits to ensure regulatory and quality standards.
• Provide biomarker operational metrics and study updates to cross‑functional teams and leadership.
• Review ICFs and respond to EC/IRB inquiries related to biomarker components.
• Utilize IRT and EDC systems to enable real‑time sample tracking and data integration.

Kenntnisse

Mentoring

Cross-functional collaboration

Biomarker operations

CDx knowledge

Problem solving

Critical thinking

Team player

Ausbildung

Life sciences degree (BS or MS)

Tools

Microsoft Excel

Microsoft PowerPoint

LIMS platforms

Project management tools

Jobbeschreibung

Revolution Medicines is seeking a Manager, Biospecimen Operations within Translational Medicine to provide biomarker operational expertise for Phase I–III oncology trials. You will lead end‑to‑end biomarker operations, coordinate with cross‑functional teams, and drive SOPs and vendor efforts to ensure quality and regulatory alignment.

The role requires a Life Sciences degree with 7+ years in clinical research or clinical diagnostics, mentoring experience, and strong skills in Excel/PowerPoint.