Director, Toxicology

Scorpion Therapeutics; San Francisco (CA); On-site; USD 204,000 - 284,000; Full time

Benefits offered by this job

Health/welfare plans

Non-accrual paid time off

Holiday shutdown

Commuter benefits

401K match

Lunch daily in the office

Job summary

Vir Biotechnology is seeking a Director, Toxicology to lead nonclinical safety strategies across infectious disease and oncology programs in a fast-paced R&D environment.

The role requires a DVM or PhD in Pharmacology/Toxicology or Biomedical Sciences, ideally with a DABT certification, and 12+ years in biologics/pharma R&D. You will oversee GLP/non-GLP studies and interact with regulatory authorities to advance candidates to licensure.

Qualifications

• Minimum doctoral or veterinary degree in pharmacology/toxicology or biomedical sciences.
• Strong scientific writing and communication skills.
• Experience with regulatory toxicology is required.
• Leadership and collaboration across cross-functional teams.

Responsibilities

• Develop and execute nonclinical toxicology strategy across development programs.
• Oversee GLP and non-GLP nonclinical safety studies in compliance with regulations and SOPs.
• Design, review, and interpret nonclinical toxicology study reports; finalize reports for regulatory requirements.
• Lead development and review of regulatory documents (CTAs, IMPDs, INDs, BLAs) and interact with regulators.
• Partner with Regulatory, Clinical, CMC and external collaborators to integrate nonclinical activities into development plans.
• Contribute to departmental SOPs and templates.
• Maintain current understanding of relevant literature and methodologies.
• Work in multidisciplinary teams to advance candidates into development and licensure.
• Generate literature reviews.

Education

DVM or PhD in Pharmacology/Toxicology or Biomedical Sciences

DABT Certification

Tools

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.