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Salary: USD 203,500 - 284,000 / annual
Vir Biotechnology is a clinical-stage biopharmaceutical company focused on discovering and developing medicines for serious infectious diseases and cancer. The company's 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.
We are seeking an experienced Director of Clinical Operations to provide strategic and operational leadership for global oncology clinical trials. This is a hands-on study leader role 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 large, complex early-phase oncology studies and may oversee additional studies as the portfolio expands. Key responsibilities include leading Study Management Teams, managing CROs and vendors, driving study strategy and execution, and ensuring 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.
Specific duties include: serving as study owner with accountability for timelines, budget, quality, and milestones; providing strategic leadership for first-in-human, dose-escalation, dose-optimization, and expansion-cohort studies; developing and executing global site and enrollment strategies; leading Study Management Teams and cross-functional decision-making; acting as primary point of accountability for external partners; developing and maintaining study timelines, budgets, and risk management plans; authoring and reviewing protocols and study documents; partnering with Clinical Development, Regulatory Affairs, Safety, and other functions; providing operational leadership for regulatory submissions and inspection readiness; leading vendor selection activities; overseeing clinical monitoring and sponsor oversight visits; driving continuous improvement through SOP development and process optimization; implementing risk-based quality management plans; representing Clinical Operations on cross-functional teams and alliance governance forums; supporting operational planning for emerging oncology assets; and mentoring junior Clinical Operations colleagues.
The role is located in San Francisco headquarters with an expectation of at least 3 days per week in office.
REQUIREMENTS:
- Bachelor's degree in Life Sciences or related field
- 12+ years of clinical development experience within 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, or cytokine-based therapies
- 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 with 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 fast-paced biotechnology environment
- Experience contributing to departmental initiatives, process improvements, and operational excellence programs
- Ability to travel domestically and internationally as needed
