Director, Translational Biology
Vir Biotechnology, Inc.
12 hours ago
Remote friendly (San Francisco, CA)
United States
Clinical Research and Development
What You'll Do
- Serve as the biomarker lead for specific programs from preclinical through clinical development
- Develop and execute biomarker strategies, including design and oversight of preclinical biomarker assessments and contribution to clinical biomarker plans to inform dose selection and development of immune-oncology agents
- Plan and oversee validation and execution of human immunologic and molecular methods in preclinical and clinical studies to meet biomarker objectives
- Support regulatory deliverables and documentation (e.g., INDs, BLAs/NDAs), and contribute to authoring INDs, IBs, clinical study protocols, and related documents
- Manage pilots and method validation with external vendors to ensure robust, fit-for-purpose biomarker assays
- Collaborate with discovery, clinical, and data science teams to refine biomarker hypotheses, design studies, and analyze key datasets
- Lead a team by providing scientific guidance and mentorship in immunology and biomarkers
- Represent the Research function in selected external meetings
- Develop and manage internal/external resources (CROs, academic collaborators) to advance biomarker discovery and implementation
Who You Are and What You Bring
- PhD with 10+ years, or MS with 13+ years experience in immune-oncology/immunology; drug and biomarker development from preclinical through Ph1–3
- Proven track record in biomarker identification, validation, and characterization in vitro/in vivo for MOA, dose selection, and patient stratification
- Deep immunology and immune-oncology expertise
- Proficiency with immunology assays (e.g., polychromatic flow cytometry, cytotoxicity, T cell function, antigen presentation)
- Ability to develop and implement qualified/validated biomarker methods for clinical use; oversee assay pilots and vendor/CRO method validation
- Background contributing to regulatory documents
- Familiarity with diagnostic/companion diagnostic tests for patient enrichment/selection/prediction
- Demonstrated scientific and people leadership, including managing scientists and leading cross-functional teams
Application instructions: Not provided.
- Serve as the biomarker lead for specific programs from preclinical through clinical development
- Develop and execute biomarker strategies, including design and oversight of preclinical biomarker assessments and contribution to clinical biomarker plans to inform dose selection and development of immune-oncology agents
- Plan and oversee validation and execution of human immunologic and molecular methods in preclinical and clinical studies to meet biomarker objectives
- Support regulatory deliverables and documentation (e.g., INDs, BLAs/NDAs), and contribute to authoring INDs, IBs, clinical study protocols, and related documents
- Manage pilots and method validation with external vendors to ensure robust, fit-for-purpose biomarker assays
- Collaborate with discovery, clinical, and data science teams to refine biomarker hypotheses, design studies, and analyze key datasets
- Lead a team by providing scientific guidance and mentorship in immunology and biomarkers
- Represent the Research function in selected external meetings
- Develop and manage internal/external resources (CROs, academic collaborators) to advance biomarker discovery and implementation
Who You Are and What You Bring
- PhD with 10+ years, or MS with 13+ years experience in immune-oncology/immunology; drug and biomarker development from preclinical through Ph1–3
- Proven track record in biomarker identification, validation, and characterization in vitro/in vivo for MOA, dose selection, and patient stratification
- Deep immunology and immune-oncology expertise
- Proficiency with immunology assays (e.g., polychromatic flow cytometry, cytotoxicity, T cell function, antigen presentation)
- Ability to develop and implement qualified/validated biomarker methods for clinical use; oversee assay pilots and vendor/CRO method validation
- Background contributing to regulatory documents
- Familiarity with diagnostic/companion diagnostic tests for patient enrichment/selection/prediction
- Demonstrated scientific and people leadership, including managing scientists and leading cross-functional teams
Application instructions: Not provided.