VP, Healthcare Law at Vir Biotechnology

The VP, Healthcare Law will serve as lead counsel for all healthcare law matters related to product candidates, including reviewing scientific, clinical, and medical publications and participating in cross-functional committees for clinical and commercial development. They will support clinical operations by reviewing Informed Consent Forms, managing adverse events and patient injury issues, and handling site-specific issues and study promotions. The role involves advising internal teams on clinical, commercial, privacy, and governmental legal matters, including FOIA requests, and providing guidance on healthcare laws and regulations affecting biopharmaceutical products and operations. This includes compliance, fraud and abuse, privacy, pharmacovigilance, product liability, advertising/labeling, and matters related to investigational and commercial therapeutic products. Additionally, they will lead the Legal function on data privacy matters for clinical operations, support internal teams on healthcare compliance related to FDCA, FDA guidance, PhRMA Code, Sunshine Act, HIPAA, Stark Law, Anti-Kickback Statute, GDPR, and similar regulations, and provide regulatory and compliance guidance for transactional agreements such as clinical trial, consulting, speaker, advisory board, and vendor agreements, including compliance guidance for contracting with HCPs and conducting FMV analysis.