Associate Director, Clinical Biomarkers

CONTRACT ROLE – Associate Director, Clinical Biomarkers

Watertown, MA – CONTRACT POSITION

This contract position, with a duration of 12 months with the possibility to extend or potential contract to perm opportunity. Reporting to the Senior Vice President of Immunology Research and Early Translational Development, the Associate Director, Clinical Biomarkers will serve as a key individual contributor responsible for refining and implementing our clinical biomarker strategy across one or more clinical programs. This role will partner closely with key functions across company including Clinical Development, Clinical Operations, and external CROs to ensure high-quality clinical biomarker data to support company’s clinical and regulatory objectives.

• Refine and help evolve the program clinical biomarker strategy as new nonclinical and clinical data emerge, in partnership with the Head of Immunology Research and Early Translational Development.
• Define and own the clinical biomarker operational plan — translating strategy into a concrete plan for sample collection, assay execution, timelines, and deliverables across ongoing and upcoming clinical studies.
• Assess, recommend, and manage external CROs conducting clinical biomarker assay work, including scientific and operational due diligence, statement of work development, and ongoing performance oversight.
• Review and interpret clinical biomarker data as it comes in, ensuring data quality and providing balanced, scientifically grounded interpretation that accounts for assay variability, biological complexity, and program context.
• Partner with CROs and internal stakeholders to troubleshoot assay performance issues and keep data generation on track for clinical sample readiness milestones.
• Collaborate cross-functionally with Clinical Development, Clinical Operations, and the Immunology Biology team to ensure biomarker data supports go/no-go decisions and broader program strategy.
• Contribute biomarker-related content to internal program updates, regulatory documents, and other program materials as needed.
• Help build out the biomarker-related documentation and processes needed to support the program through Phase 1 and into Phase 2.

• Advanced degree (PhD, MD, or equivalent) in immunology, pharmacology, biology, or a related field required.
• Experience developing and/or implementing clinical biomarker strategies in a biotech or pharmaceutical setting preferred.
• Experience assessing, selecting, and overseeing CROs for clinical biomarker or bioanalytical assay work strongly preferred.
• Demonstrated ability to review and interpret complex biomarker or immunoassay data and communicate findings clearly to both scientific and clinical audiences.
• Background in immunology, transplantation, or related therapeutic areas is a plus.
• Comfortable operating independently in a small, fast-moving team, with strong written and verbal communication skills.
• Availability for a contract engagement, with an on-site presence in Watertown, MA.