Director, Clinical Operations

The role

The Director, Clinical Operations provides strategic and operational leadership for global oncology clinical trials. This person will serve as a hands-on study leader for complex early-phase oncology studies and manage CROs and vendors.

What you will do

• Serve as the Clinical Operations lead and study owner for global oncology clinical trials
• Provide strategic and operational leadership for early-phase oncology studies
• Provide operational input into Clinical Development Plans and program strategy
• Develop and execute global site and enrollment strategies
• Lead Study Management Teams and drive cross-functional decision-making
• Act as the primary point of accountability for CROs, central laboratories, and technology vendors
• Develop and maintain study timelines, budgets, forecasts, and risk management plans
• Author, review, and provide operational input into protocols and study documents
• Partner with cross-functional teams to integrate operational and clinical objectives
• Lead vendor selection activities including RFP development and contracting

Required qualifications

• Bachelor's degree in Life Sciences or related field
• 12+ years of clinical development experience within the biotechnology or pharmaceutical industry
• Significant experience leading complex global oncology clinical trials
• Deep expertise in early-phase oncology development
• Demonstrated experience leading first-in-human and early-development oncology trials
• Demonstrated expertise in global study start-up, site strategy, enrollment optimization, and recruitment planning
• Strong understanding of clinical trial design and execution
• 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
• Ability to travel domestically and internationally as needed

Nice to have

• Experience supporting development of novel oncology modalities, such as T-cell engagers, bispecific antibodies, immuno-oncology therapies, cell therapies, cytokine-based therapies, or related platform
• Experience contributing to departmental initiatives, process improvements, and operational excellence programs

Benefits

• health and welfare benefit plans
• non-accrual paid time off
• company shut down for holidays
• commuter benefits
• 401K match
• lunch each day in the office

Before you apply

• Applicants must currently be authorized to work for any employer in the U.S.
• Unable to sponsor or take over sponsorship of an employment Visa at this time

About the company

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.