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Vir Biotechnology is seeking a Senior Director of Clinical Research to serve as Medical Director and Medical Monitor for its oncology clinical development program. This is a physician leadership role responsible for medical oversight, safety monitoring, and clinical decision-making across Phase 1-3 oncology trials focused on the company's PRO-XTEN® dual-masked T-cell engager platform for solid tumors.
Key responsibilities include: serving as lead Medical Monitor for one or more oncology clinical trials with ongoing patient-level clinical oversight; reviewing and interpreting emerging safety and efficacy data, assessing adverse events, and partnering with Pharmacovigilance on benefit-risk assessments; acting as primary medical contact for investigators and study sites on eligibility, safety management, protocol implementation, and clinical questions; leading medical monitoring activities across Phase 1-3 studies to ensure data integrity, protocol compliance, and regulatory readiness; contributing to protocol development, amendments, informed consent forms, safety management plans, clinical study reports, and regulatory submissions; partnering with Clinical Operations, Clinical Scientists, Biometrics, Regulatory, and Safety teams; presenting clinical findings and safety updates to governance committees, executive leadership, and regulatory agencies; participating in investigator meetings, safety review committees, and advisory boards; and mentoring junior team members.
Required qualifications: MD with 12+ years of clinical research and drug development experience in biotech, pharma, academic, or CRO settings; deep experience as Medical Monitor and Clinical Research Physician in oncology drug development; strong expertise in patient safety oversight and medical monitoring across oncology trials; demonstrated experience with Phase 1, 2, and 3 studies; ability to review and interpret patient-level safety and efficacy data; strong understanding of oncology trial design, GCP/ICH guidelines, regulatory requirements, and safety reporting; experience collaborating with Pharmacovigilance teams on safety signals and benefit-risk assessments; excellent communication skills for engaging investigators and cross-functional teams. Board certification in Oncology, Hematology/Oncology, or related specialty strongly preferred. Experience supporting regulatory submissions and health authority interactions preferred.
Role is based in San Francisco headquarters with expectation of at least 3 days per week in office.
