Treeline · 4 months ago
Clinical Biomarkers Lead
Treeline Biosciences is focused on advancing precision medicine, and they are seeking a Clinical Biomarkers Lead to oversee biomarker planning and execution across all clinical programs. The role involves managing assay transfer, ensuring data quality, and collaborating with various teams to align biomarker deliverables with clinical needs.
BiotechnologyHealth CareLife ScienceMedicalPrecision 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
Qualification
Required
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
Preferred
Oncology experience strongly preferred
Immunology and/or neuroscience experience considered upside
Experience with development of companion diagnostics (CDx) considered a plus
Company
Treeline
Treeline (or Treeline Biosciences) is a privately held, clinical-stage biopharma company that aspires to make medicines at the highest level.
H1B Sponsorship
Treeline has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (4)
2023 (3)
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
$1.09BKey Investors
AI Life Sciences Investments LLCKohlberg Kravis Roberts
2025-09-03Series A· $200M
2024-10-17Undisclosed· $421M
2022-10-11Series A· $261.27M
Recent News
Boston Globe
2026-01-16
2025-10-04
2025-10-01
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