THE OPPORTUNITY
Vir Bio is looking for a Director, Translational Biology to drive biomarker strategy across our pipeline, from preclinical discovery through clinical development. Reporting to the VP, Translational Biology, you will translate complex immunologic and molecular insights into actionable plans that inform mechanism of action, dose selection, patient selection, and clinical outcomes in immune-oncology and related disease areas.
You will lead biomarker design and execution for key programs, oversee advanced translational assays in both preclinical models and human samples, and partner closely with discovery, clinical, data science, and external collaborators to deliver high-quality biomarker data. You will manage scientists, contribute to regulatory filings, and help build the infrastructure and partnerships needed to advance cutting-edge biomarker science.
This role is located in our San Francisco headquarters with an expectation of at least 3 days per week in office.
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 the validation and execution of human immunologic and molecular methods in preclinical and clinical studies to meet biomarker objectives
- Support activities related to deliverables and documentation for regulatory submissions (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 colleagues to refine biomarker hypotheses, design studies, and analyze and interpret key datasets
- Lead a team, providing scientific guidance and mentorship in immunology and biomarkers while overseeing team performance and development
- Represent the Research function in selected external meetings, providing scientific input to support partnerships, due diligence, and program evaluations
- Help develop and manage internal and external resources, including CROs and academic collaborators, to advance biomarker discovery and implementation
WHO YOU ARE AND WHAT YOU BRING
- PhD and 10+ years, or MS and 13+ years, of relevant industry-focused experience in immune-oncology, immunology, or a closely related field, including drug and biomarker development from preclinical through Ph1–3 clinical stages
- Proven track record in designing and executing biomarker strategies, encompassing biomarker identification, validation, and characterization 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)
- Demonstrated ability to develop and implement 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 the development or application of diagnostic or companion diagnostic tests for patient enrichment, selection, or prediction of therapeutic efficacy
- Demonstrated scientific and people leadership, including managing scientists and leading cross-functional translational or biomarker teams
