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Salary: USD 235,500 - 329,000 / annual
Vir Biotechnology is a clinical-stage biopharmaceutical company focused on discovering and developing medicines for serious infectious diseases and cancer. The company has exclusive rights to the PRO-XTEN® masking platform for oncology and infectious disease, with a clinical-stage portfolio including programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications.
The Senior Director of Clinical Operations will provide portfolio-level strategic and operational leadership for multiple complex global oncology programs. This is a hands-on leadership role 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 affecting program objectives.
Key responsibilities include:
- Oversee 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
- Partner with Clinical Development, Translational Medicine, Clinical Pharmacology, Medical Monitoring, Biometrics, Regulatory Affairs, Safety, and other functions to align operational and clinical objectives
- Translate program strategy into integrated operational plans encompassing country and site strategy, start-up and enrollment assumptions, patient and site engagement, vendor and CRO selection, resourcing, budget, and risk mitigation
- Provide effective sponsor oversight of CROs and ancillary vendors through clear governance, performance metrics, issue escalation, quality and risk review, and financial oversight
- Implement and oversee risk-based quality management plans, sponsor-oversight activities, and inspection-readiness strategies
- Drive Clinical Operations excellence by serving as subject matter expert and leading cross-functional initiatives including KPI tracking and process improvement
- Build, lead, and develop a high-performing Clinical Operations team through effective management, coaching, and professional development
- Mentor junior Clinical Operations colleagues and contribute to building organizational capabilities
- Develop company SOPs, guidelines, and efficient systems in collaboration with the Clinical Operations team
- Represent Clinical Operations on program, study, governance, and portfolio planning teams
- Serve as operational lead for alliance and co-development programs
- Lead Clinical Operations planning for emerging oncology assets transitioning from preclinical development into the clinic
The role is based at San Francisco headquarters with an expectation of working in the office at least three days per week.
REQUIREMENTS:
- Bachelor's degree in life sciences or related field
- 15+ years of clinical development experience in biotechnology or pharmaceutical industry
- Significant experience overseeing 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, country and site feasibility, investigator engagement, enrollment forecasting and 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 other 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 leadership with hands-on execution, make timely decisions with incomplete or evolving data, and resolve complex operational issues in fast-paced, resource-conscious biotechnology environment
- Proven ability to influence cross-functional program strategy and drive timely decisions
- Experience contributing to departmental initiatives, process improvements, and operational excellence programs
- Ability to travel domestically and internationally as needed
