Senior Director, Clinical Operations

The role

This person will provide strategic and operational leadership for multiple complex global oncology programs. They will translate clinical development strategy into executable plans and oversee CROs, clinical sites, and vendors.

What you will do

• Oversee tactical implementation of clinical development plans for global oncology trials
• Provide leadership for first-in-human, dose-escalation, and expansion-cohort oncology studies
• Partner with cross-functional teams to align operational and clinical objectives
• Translate program strategy into integrated operational plans
• Provide sponsor oversight of CROs and ancillary vendors
• Implement risk-based quality management plans and inspection-readiness strategies
• Drive Clinical Operations excellence through KPI tracking and process improvement
• Build, lead, and develop a high-performing Clinical Operations team
• Develop company SOPs, guidelines, and efficient systems
• Serve as operational lead for alliance and co-development programs

Required qualifications

• Bachelor’s degree in life sciences or a related field
• 15+ years of clinical development experience in the biotechnology or pharmaceutical industry
• Significant experience overseeing complex global oncology clinical trials
• Deep expertise in early-phase oncology development
• Demonstrated experience leading first-in-human and early-development oncology trials
• Experience supporting development of novel oncology modalities
• Demonstrated expertise in global study start-up, country and site feasibility, investigator engagement, enrollment forecasting and optimization, and recruitment planning
• Strong understanding of clinical trial design and execution
• 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
• Ability to travel domestically and internationally as needed

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
• Vir Biotechnology participates in E-Verify

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.