Director, Clinical Operations

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 appropriate sponsor oversight of site management and study conduct
• Conduct sponsor oversight visits, as needed, to assess site and vendor performance.
• Drive continuous improvement across Clinical Operations through SOP development, process optimization, training initiatives, and departmental projects
• Implement and oversee risk-based quality management plans, sponsor-oversight activities, and inspection-readiness strategies across assigned studies
• Represent Clinical Operations on cross-functional program teams, governance forums, and alliance teams
• Serve as the operational lead for alliance and co-development programs, representing Clinical Operations in joint governance forums and facilitating cross-company operational alignment.
• Support operational planning and study execution for emerging oncology assets transitioning from preclinical development into the clinic.
• Mentor junior Clinical Operations colleagues and contribute to building organizational capabilities that support a growing oncology portfolio.

WHO YOU ARE AND WHAT YOU BRING

• Bachelor's degree in Life Sciences or related field and 12+ years of clinical development experience within the biotechnology or pharmaceutical industry
• Significant experience leading complex global oncology clinical trials, with deep expertise in early-phase oncology development
• Demonstrated experience leading first-in-human and early-development oncology trials, including dose-escalation, backfill, expansion, signal-seeking, and dose-optimization studies.
• Experience supporting development of novel oncology modalities, such as T-cell engagers, bispecific antibodies, immuno-oncology therapies, cell therapies, cytokine-based therapies, or related platforms.
• Demonstrated expertise in global study start-up, site strategy, enrollment optimization, and recruitment planning across academic and community oncology networks
• Strong understanding of clinical trial design and execution, including operational considerations in oncology studies
• Extensive knowledge of FDA, EMA, ICH-GCP, and global regulatory requirements
• Experience managing CROs and vendors across global clinical development programs
• Experience supporting regulatory inspections, audits, and inspection readiness activities
• Demonstrated ability to balance strategic thinking with hands-on execution and operational problem-solving
• Proven ability to influence cross-functional program strategy and drive timely decisions in a fast-paced biotechnology environment
• Experience contributing to departmental initiatives, process improvements, and operational excellence programs
• Ability to travel domestically and internationally as needed.