Director/Senior Director, Clinical Biomarkers
$230,000–$300,000 year
Hybrid · San Francisco, California, United States
Job Summary
Lead the end-to-end biomarker strategy across autoimmune clinical programs; define pharmacodynamic, predictive, prognostic, and safety biomarker plans; author biomarker-related sections of protocols, IND/IMPD submissions, and regulatory briefing documents; oversee biomarker assay development and validation; analyze clinical biomarker data to inform dose selection, patient enrichment, and go/no-go decisions; collaborate with cross-functional teams to translate preclinical findings into clinical biomarker hypotheses; Manage CRO and specialty lab partnerships; help establish a robust biomarker function aligned with program needs; support regulatory interactions for biomarker strategy and companion diagnostic development.
Required Qualifications
- Ph.D. in Immunology, Molecular Biology, Cell Biology, Biochemistry, or a related life science discipline; postdoctoral training preferred
- 10+ years of industry experience in translational or clinical biomarkers, with direct contributions to clinical-stage programs in autoimmune, inflammatory, or oncology disease areas
- Deep expertise in immunology biomarker modalities including flow cytometry, multiplex immunoassay platforms (MSD, Luminex, Olink), gene expression profiling, and tissue-based assays
- Experience overseeing biomarker assay development and validation in accordance with fit-for-purpose and regulatory guidance frameworks
- Strong understanding of translational biology in autoimmune or inflammatory disease; familiarity with relevant disease mechanisms (e.g., cytokine networks, B/T cell biology, complement, innate immune pathways) is essential
- Experience interpreting biomarker data in the context of other clinical or nonclinical data to generate actionable mechanistic and translational insights
- Proven ability to author biomarker content for regulatory submissions and communicate findings to technical and non-technical audiences
- Familiarity with companion diagnostic development pathways and regulatory frameworks (FDA, EMA)
- Track record of effective CRO and vendor management in a resource-constrained, fast-moving biotech environment
- Collaborative scientific leader with the communication skills and strategic perspective to influence program decisions at all levels of the organization
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