Director, Toxicology

THE OPPORTUNITY

Vir Biotechnology is seeking an experienced Director, Toxicology to lead nonclinical safety strategies across the infectious disease and oncology portfolio.

What You’ll Do

• Develop and execute nonclinical toxicology strategy across multiple development programs from candidate selection through registration and life cycle management
• Oversee nonclinical safety studies (GLP and non-GLP) in compliance with regulations and company SOPs
• Design, review, and interpret nonclinical toxicology study reports; finalize reports to meet global regulatory and compliance requirements
• Lead development and review of regulatory documents (CTAs, IMPDs, INDs, BLAs, etc.) and interact with regulatory authorities
• Partner with internal stakeholders (Regulatory, Clinical, CMC) and external collaborators to integrate nonclinical activities into development plans
• Contribute to departmental procedures (SOPs and templates)
• Maintain current understanding of relevant literature and methodologies
• Work in multidisciplinary teams to bring candidates into development and through licensure
• Generate literature reviews

Who You Are and What You Bring

• DVM or PhD in Pharmacology/Toxicology or Biomedical Sciences
• DABT Certification (strongly preferred)
• 12+ years industry experience in biologics/pharma R&D (preferably oncology and infectious disease)
• Working knowledge of FDA, EMA, and ICH guidance including GLP regulations
• Experience authoring regulatory submissions (e.g., INDs, BLAs) and responding to regulatory inquiries
• Functional understanding of QA, regulatory, and clinical responsibilities
• Excellent scientific written and oral communication
• Ability to collaborate cross-functionally; willingness to learn; high attention to detail; ability to lead and drive consensus

Benefits/Compensation

• Expected salary range: $203,500 to $284,000 per year; package includes bonus and equity and benefits such as health/welfare plans, non-accrual paid time off, holiday shut down, commuter benefits, 401K match, and lunch each day in the office.