Manager, Clinical Biomarker Operations

Role

Manager, Biospecimen Operations within Translational Medicine, supporting phase III oncology trials with biomarker operational expertise.

Responsibilities

• oversee end-to-end biomarker activities including protocol review, sample lifecycle management, vendor coordination, central lab startup, and operational process optimization
• collaborate with cross-functional teams (Biomarker Leads, Clinical Ops, Data Management)
• support regulatory submissions and CDx filings
• manage vendor qualification and audits
• provide metrics and updates for senior leadership

Requirements

• BS/MS in life sciences
• 7+ years in clinical research or diagnostic labs
• experience in biomarker and CDx operations, especially in phase 1–3 oncology trials
• proficiency in sample management systems (e.g., TruTech, SLOPE, LIMS) and NGS methods
• strong communication, planning, and multitasking skills
• Preferred: experience with Project Management tools, LIMS, and NGS for RAS mutation analysis

High-Value

oncology, phase 1-3 trials, biomarker/CDx operations, regulatory submissions, central laboratory oversight, real-time sample tracking, cross-functional collaboration.

WorkSetup

based in Redwood City, CA; salary range $143,000–$178,000 USD; onsite with possible travel.