Clinical Biomarkers Lead

Clinical Biomarkers Lead

The Clinical Biomarkers Lead will be accountable for biomarker planning and execution across all clinical programs. This includes designing biomarker plans for each program, identifying appropriate bioassay labs/CROs, managing assay transfer and validation studies, and ensuring biomarker data are ingested, tracked, QCed, and integrated efficiently. The successful candidate will serve as the central point of accountability for biomarker operations, enabling high-quality and timely data delivery that supports Treeline’s mission to advance precision medicine.

Responsibilities

• Develop and oversee biomarker plans for each clinical protocol.
• Identify and qualify bioassay labs/CROs for biomarker assays
• Lead assay transfer from Discovery/Translational teams to bioassay labs/CROs, ensuring validation and qualification.
• Work with Clinical Operations to implement sample logistics across all studies.
• Oversee testing at bioassay labs/CROs, ensuring quality, compliance, and adherence to protocol requirements.
• Define and manage data ingestion processes, ensuring biomarker data are QC’ed and integrated into study databases.
• Collaborate with Clinical Development, Clinical Operations, Translational Biology, Data Management, Biostatistics, and Regulatory to ensure biomarker deliverables align with clinical program needs.
• Provide updates on biomarker sample status, testing timelines, and data readiness to internal stakeholders.
• Establish and refine best practices, SOPs, and KPIs for sample management, testing, and biomarker data flow.
• Work with Translational Biology and Clinical Development colleagues to analyze biomarker data and test key program hypotheses.

Qualifications

• Advanced degree (PhD, MS, or equivalent) in Life Sciences, Cell Biology, Molecular Biology, Immunology, or a related field.
• 7 years of experience in clinical biomarkers, translational medicine, or related function within biotech/pharma.
• Proven expertise in assay transfer, validation, and qualification with CRO and lab oversight experience.
• Knowledge of biomarker assay platforms (flow cytometry, IHC, NGS, proteomics, ligand binding assays) and their clinical application.
• Experience in sample tracking, reconciliation, and biomarker data ingestion processes.
• Familiarity with ICH-GCP, regulatory expectations, and data integration standards (e.g., CDISC, SDTM).
• Excellent organizational, cross-functional leadership, and communication skills, with the ability to manage multiple programs in a fast-paced environment.
• Oncology experience strongly preferred. Immunology and/or neuroscience experience considered upside.
• Experience with development of companion diagnostics (CDx) considered a plus.

This position is classified as exempt. The anticipated annual base salary range for candidates who will work in San Diego is $175,950 to $215,000. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, education, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.

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