THE OPPORTUNITY
Vir Bio is looking for a Director, Translational Biology to drive biomarker strategy across the pipeline, from preclinical discovery through clinical development.
What Youβll Do
- Serve as biomarker lead for specific programs from preclinical through clinical development
- Develop and execute biomarker strategies, including preclinical biomarker assessments and clinical biomarker plans to inform dose selection and development
- Plan and oversee validation and execution of human immunologic and molecular methods in preclinical and clinical studies
- Support regulatory submission deliverables/documentation (e.g., INDs, BLAs/NDAs) and contribute to INDs, IBs, clinical study protocols, and related documents
- Manage pilots and method validation with external vendors to ensure robust biomarker assays
- Collaborate with discovery, clinical, and data science to refine hypotheses, design studies, and analyze datasets
- Lead a team, providing scientific guidance and mentorship in immunology and biomarkers
- Represent the Research function in selected external meetings
- Develop and manage internal/external resources (e.g., CROs, academic collaborators) to advance biomarker discovery and implementation
Who You Are And What You Bring
- PhD + 10+ years, or MS + 13+ years in immune-oncology/immunology; drug and biomarker development from preclinical through Ph1β3
- Proven track record designing/executing biomarker strategies (identification, validation, characterization in vitro/in vivo)
- Deep expertise in immunology and immune-oncology
- Proficiency with immunology assays (e.g., polychromatic flow cytometry, cytotoxicity, T cell function, antigen presentation)
- Experience developing/implementing validated biomarker methods for clinical use; oversight of assay pilots and method validation with vendors/CROs
- Background contributing to regulatory documents
- Familiarity with diagnostic/companion diagnostic development for patient enrichment/selection/prediction
- Demonstrated scientific and people leadership (managing scientists; leading cross-functional teams)
Application instructions
- Applicants must be authorized to work in the U.S.; Vir is unable to sponsor or take over visa sponsorship.