Clinical Biomarkers Lead

Treeline; Watertown (MA); On-site; USD 187,200 - 200,000; Full time

Job summary

Treeline Biosciences in Watertown, MA is seeking a Biomarker Lead to drive biomarker planning and execution across early and late clinical programs, design biomarker plans, identify labs/CROs, and supervise assay transfer and data QC.

Candidates should hold a PhD with postdoc training and 4–5 years of biotech/pharma biomarker experience; expertise in assay transfer, validation, and platforms (flow cytometry, IHC, NGS). Oncology experience is highly preferred.

Qualifications

• PhD with postdoctoral training in life sciences or related field.
• 4–5 years of industry biomarker experience in biotech/pharma.
• Expertise in assay transfer, validation and CRO oversight.
• Knowledge of biomarker platforms (flow cytometry, IHC, NGS, proteomics).
• Strong leadership, organization and cross-functional communication.
• Oncology experience preferred; CDx development is a plus.

Responsibilities

• Develop and oversee biomarker plans for each clinical protocol.
• Identify and qualify bioassay labs/CROs for biomarker assays.
• Lead assay transfer from Translational biology to labs/CROs.
• Oversee testing at labs/CROs ensuring QC and protocol adherence.
• Collaborate with Clinical Development, Data Management, Biostatistics, and Regulatory.
• Provide updates on biomarkers to internal stakeholders.
• Analyze biomarker data with translational and clinical teams.

Skills

Cross-functional leadership

Communication

Project management

Biomarker data analysis

Biomarker platforms

Education

PhD in Life Sciences (or related field)

Postdoctoral training

Tools

Flow cytometry

IHC

NGS

Proteomics

Assay transfer & CRO oversight

Job description

Biomarker Lead

The Biomarker Lead will be accountable for biomarker planning and execution across one to two clinical programs, with a focus on programs approaching or in the clinic. 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 biomarkers for their program, enabling high-quality and timely data delivery that supports Treeline’s mission to advance precision medicine.

• Develop and oversee biomarker plans for each clinical protocol.
• Identify and qualify bioassay labs/CROs for biomarker assays
• Lead assay transfer from Translation biology teams to bioassay labs/CROs, ensuring validation and qualification.
• Oversee testing at bioassay labs/CROs, ensuring quality, compliance, and adherence to protocol requirements.
• 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 biomarkers to internal stakeholders.
• Work with Translational Biology and Clinical Development colleagues to analyze biomarker data and test key program hypotheses.

• PhD with postdoctoral training in Life Sciences, Cell Biology, Molecular Biology, Immunology, or a related field.
• 4-5 years of industry experience in a clinical setting, in clinical biomarkers, translational medicine, or a 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.
• Excellent organizational, cross-functional leadership, and communication skills, with the ability to manage multiple workstreams across one to two 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 Watertown is $187,200 - $200,000. 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, 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.