Senior Director, Clinical Operations Oncology at Vir Biotechnology in San Francisco, CA

Job description

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN ® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology has exclusive rights to the universal PRO-XTEN ® masking platform for oncology and infectious disease. PRO-XTEN ® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company. We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best. THE OPPORTUNITY Vir Biotechnology is seeking an experienced Senior Director of Clinical Operations to provide portfolio-level strategic and operational leadership for multiple complex global oncology programs. This individual will be accountable for translating clinical development strategy into executable operational plans, delivering studies against timelines, budgets, quality standards, and decision-critical milestones, and proactively identifying and resolving risks that could affect program objectives. The role will serve as a hands-on leader across study execution, program governance, alliance management, operational excellence, and oncology portfolio growth. You will establish the operational strategy for assigned programs and provide effective sponsor oversight of CROs, clinical sites, laboratories, and specialty vendors. As a key member of cross-functional program and study teams, you will provide operational leadership from protocol concept and country and site strategy through database lock, study closeout, and regulatory submission support. You will also lead Clinical Operations initiatives that strengthen portfolio governance, resource planning, process improvement, SOP development, inspection readiness, and scalable operating capabilities. This role is based at our San Francisco headquarters, with an expectation of working in the office at least three days per week. WHAT YOU'LL DO Oversee the tactical implementation of clinical development plans for multiple global oncology trials, with accountability for delivery against timelines, budgets, quality standards, and milestones Provide strategic and operational leadership for first-in-human, dose-escalation, dose-optimization, backfill, combination, and expansion-cohort oncology studies, including rapid cohort activation, fit-for-purpose safety oversight, intensive pharmacokinetic and biomarker sampling, and timely delivery of data to support dose, indication, and portfolio decisions. Partner closely with Clinical Development, Translational Medicine, Clinical Pharmacology, Medical Monitoring, Biometrics, Regulatory Affairs, Safety, Clinical Supply, and other functions to align operational and clinical objectives and ensure consistency across assigned studies Translate program strategy into an integrated operational plan encompassing country and site strategy,, start-up and enrollment assumptions, patient and site engagement, vendor and CRO selection, resourcing, budget, clinical supply interfaces, data-delivery milestones, and scenario-based risk mitigation. Provide effective Sponsor oversight of CROs and ancillary vendors through clear governance, performance metrics, issue escalation, quality and risk review, financial oversight, and documented accountability for timely corrective and preventive actions. Implement and oversee risk-based quality management plans, sponsor-oversight activities, and inspection-readiness strategies across all assigned studies Drive Clinical Operations excellence by serving as the Clinical Operations subject matter expert for assigned clinical studies and