Job Description

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.

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Job Tags

Work at office

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