Biomarker Clinical Assay Lead Manager

Position Summary

This position will sit within the Assay Development Group of the Companion Diagnostic Center of Excellence supporting clinical biomarker and diagnostic strategy development through scientific and technical oversight of biomarker and prototype diagnostic assays, clinical implementation, and management of external and internal partners in oncology and other therapeutic areas. You will bring technical leadership to devise scientifically sound biomarker and diagnostic testing strategies, effective implementation of assays into clinical trials, and communicate data and program impacts to key stakeholders and project teams.

• Provide bio-analytical assay technical and operational expertise to Study Teams to ensure delivery of high-quality clinical biomarker and diagnostic data.
• Support assay development, validation and timely availability of fit-for-purpose and diagnostic (Dx) clinical biomarker assays to clinical Study Teams.
• Function as key point of contact with external and internal clinical labs, with oversight responsibilities for agreements, work plans, budget and invoices, assay development, transfer, validation and associated reports, sample analyses and data transfers, and overall data quality.
• Provide technical support for selection, qualification and periodic audits of bioanalytical laboratories supporting oncology clinical trial biomarker and diagnostic assays.
• Collaborate with Study Teams to ensure appropriate biomarker and diagnostic sample handling and processing steps are performed during clinical trials.
• Serve as subject matter expert for biomarker and diagnostic testing technologies (NGS, PCR, IHC, flow cytometry, immuno-assays, etc.).
• Collaborate with Asset Teams to manage the timely testing of clinical trial samples and the analysis and reporting of the associated data.

• PhD in a relevant scientific field (e.g., pathology, immunology, oncology, molecular biology, genetics) or
• MS in a relevant scientific field (e.g., pathology, immunology, oncology, molecular biology, genetics) with 2+ years of relevant experience or
• BA with 4+ years of relevant experience.
• Experience with the research and development of biologic therapeutics, biomarker and diagnostic assay development, validation and execution in clinical trials.
• Experience and expertise in biomarker selection trials.
• An understanding of translational approaches as applied to clinical trial design and regulatory processes, proof‑of‑concept studies, and the implementation of biomarkers and diagnostic assays.
• Development, validation, and implementation of a broad range of platform technologies within clinical trials (e.g., NGS, IHC, PCR, FISH, flow cytometry, other cell‑based and circulating biomarker technologies).
• Demonstrated understanding of clinical laboratory regulatory and compliance requirements (GLP, GCP, GCLP, CLIA, CAP).
• Demonstrated ability to think strategically and creatively while contributing to multiple projects simultaneously.
• Experience working productively in a collaborative, multi‑disciplinary and diverse team setting.
• Excellent communication and organizational skills; able to convey complex scientific and business issues to devise, reach agreement on, and implement solutions.
• Experience collaborating, leading, influencing, and motivating others.

• CRO management and outsourcing engagement expertise.
• PhD or MS degrees.

• Last Date to Apply:
  March 2, 2026
• Work Location Assignment:
  Hybrid
• Annual base salary range: $106,000–$171,500
• Bonus target: 15% of base salary
• Eligible for share‑based long‑term incentive program.