Director, Toxicology Job at Scorpion Therapeutics, San Francisco, CA

  • Scorpion Therapeutics
  • San Francisco, CA

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. #J-18808-Ljbffr

Job Tags

Work at office

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