Associate Director, Clinical Biomarkers

Key Responsibilities

• 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.

Qualifications

• 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.