Director, Translational Biology
$207,500–$261,500 year
On-site · San Francisco, California, United States
Job Summary
Director, Translational Biology to lead biomarker strategy across preclinical to clinical development in immune-oncology. Lead design and execution of biomarker plans, oversee human immunologic and molecular biomarker assays in preclinical and clinical studies, and contribute to regulatory submissions (INDs, IBs, NDAs). Manage pilots and validation with external vendors/CROs, collaborate with discovery, clinical, and data science teams to refine hypotheses and analyses, provide scientific guidance and mentorship to a biomarker team, and represent the Research function in external meetings. Will help develop and manage CROs and academic collaborators to advance biomarker discovery and implementation. Role based in San Francisco headquarters with at least 3 days/week in office.
Required Qualifications
- PhD with 10+ years of industry-focused experience in immune-oncology, immunology, or a closely related field, or MS with 13+ years of experience, including drug and biomarker development from preclinical through Ph1–3 clinical stages
- Proven track record in designing and executing biomarker strategies including identification, validation, and characterization of biomarkers in vitro and in vivo to inform mechanism of action, dose selection, and patient stratification
- Deep subject-matter expertise in immunology and immune-oncology
- Proficiency with immunology assays (e.g., polychromatic flow cytometry, cytotoxicity, T cell function, antigen presentation, and other in vitro systems)
- Experience developing and implementing robust, qualified/validated biomarker methods for clinical use, including oversight of assay pilots and method validation with external vendors/CROs
- Strong background in contributing to regulatory documents in support of translational and clinical programs
- Familiarity with development or application of diagnostic or companion diagnostic tests for patient enrichment, selection, or prediction of therapeutic efficacy
- Demonstrated scientific leadership, including managing scientists and leading cross-functional translational or biomarker teams
- Experience representing the Research function in external meetings and supporting partnerships, due diligence, and program evaluations
- Ability to develop and manage internal and external resources, including CROs and academic collaborators, to advance biomarker discovery and implementation
- Authorized to work in the United States; no visa sponsorship provided
Additional Requirements
- Authorized to work in the United States; visa sponsorship not available
- No explicit sponsorship offered
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