Director, Clinical Operations 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 Bio is seeking an experienced Director, Clinical Operations to provide strategic and operational leadership for global oncology clinical trials. The individual will serve as a hands-on study leader responsible for the successful execution of complex clinical studies while contributing to broader program strategy, alliance management, operational excellence initiatives, and portfolio expansion efforts. You will serve as the Clinical Operations lead for a large, complex early-phase oncology study and may oversee additional studies as the portfolio expands. You will lead Study Management Teams, manage CROs and vendors, drive study strategy and execution, and ensure trials are conducted to the highest standards of quality, compliance, and operational excellence. You will serve as a key member of cross-functional program teams, providing operational leadership from protocol development through study closeout. In addition to study leadership, you will contribute to Clinical Operations initiatives, including process improvements, SOP development, and inspection readiness activities. 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 Clinical Operations lead and study owner for one or more global oncology clinical trials, with accountability for successful delivery against timelines, budget, quality, and milestones Provide strategic and operational leadership for first-in-human, dose-escalation, dose-optimization, backfill, and expansion-cohort oncology studies, ensuring efficient execution and generation of high-quality data to support development decisions Provide operational input into Clinical Development Plans, program strategy, indication-expansion plans, decision gates, and portfolio-planning activities. Develop and execute global site and enrollment strategies, including investigator engagement, site feasibility, country selection, academic-center activation, and enrollment-acceleration activities Lead Study Management Teams and drive cross-functional decision-making to ensure efficient study conduct Act as the primary point of accountability for CROs, central laboratories, technology vendors, and other external partners Develop and maintain study timelines, budgets, forecasts, and risk management plans, proactively identifying and mitigating issues Author, review, and provide operational input into protocols, informed consent forms, study plans, charters, and other key study documents Partner closely with Clinical Development, Translational Medicine, Clinical Pharmacology, Medical Monitor, Biometrics, Regulatory Affairs, Safety, Clinical Supply, and other functions to integrate operational and clinical objectives into study execution plans Provide operational leadership and input for regulatory submissions, health authority interactions, and inspection readiness activities Lead vendor selection activities, including RFP development, bid evaluation, contracting, and ongoing oversight Oversee clinical monitoring activities and ensure app