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.