Director, Toxicology

The role

The Director, Toxicology will lead nonclinical safety strategies across infectious disease and oncology portfolios. This person will provide scientific leadership for toxicology and safety assessment activities from candidate selection through clinical development.

What you will do

• Develop and execute the nonclinical toxicology strategy across multiple development programs
• Oversee nonclinical safety studies in compliance with regulations and company SOPs
• Design, review and interpret nonclinical toxicology study reports
• Lead development and review of regulatory documents
• Interact with regulatory authorities as needed
• Partner with internal stakeholders and external co-collaborators
• Contribute to departmental procedures such as SOPs and templates
• Maintain understanding of significant literature and methodology
• Work as part of a multidisciplinary team
• Generate literature reviews

Required qualifications

• DVM or PhD in Pharmacology/Toxicology or Biomedical Sciences
• 12+ years of relevant experience in industry conducting biologics and pharmaceutical research and development
• Working knowledge of FDA, EMA, and ICH guidance including GLP regulations
• Experience in authoring regulatory submissions, e.g. INDs, BLA and preparing science-based responses to regulatory inquiries
• Functional understanding of QA, regulatory, and clinical responsibilities
• Excellent scientific written and oral communication skills
• Ability to work highly effectively and collaboratively with multiple departments and on cross-functional project teams
• Willingness to learn new areas of expertise
• Outstanding attention to detail working in a time sensitive, high paced environment
• Innate flexibility to work in a rapidly growing matrixed environment
• Excellent interpersonal skills

Nice to have

• DABT Certification
• Oncology and infectious disease biologics specialization

Benefits

• Compensation, bonus and equity
• 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
• 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.