Director, Toxicology

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. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN^® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.

Vir Biotechnology has exclusive rights to the universal PRO-XTEN^® masking platform for oncology and infectious disease. PRO-XTEN^® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.

We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.

THE OPPORTUNITY

Vir Biotechnology is seeking an experienced Director, Toxicology to lead nonclinical safety strategies across our infectious disease and oncology portfolio. In this role, you will provide scientific leadership for toxicology and safety assessment activities from candidate selection through clinical development, working closely with cross-functional teams and external partners to advance programs efficiently and effectively.

You will contribute to study design, data interpretation, regulatory submissions (IND and NDA/BLA), and risk assessment, while driving innovative approaches to support successful drug development. This position reports to the VP of Translational Development.

This role is located in our San Francisco headquarters with an expectation of at least 3 days per week in the office.

WHAT YOU'LL DO

• Develop and execute the 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
• Accountable for the design, review and interpretation of nonclinical toxicology study reports and report finalization consistent with the necessary global regulatory and compliance requirements
• Strong knowledge of GLP regulations and regulatory guidelines for testing biologics is required
• Leads development and review of regulatory documents (CTAs, IMPDs, INDs, BLAs, etc) and interact with regulatory authorities as needed
• Partner with and provide subject matter expertise to key internal stakeholders (e.g. Regulatory, Clinical, CMC) and their external co-collaborators to ensure proper integration of nonclinical activities into overall development plans
• Contribute to the departmental procedures such as SOPs and templates
• Maintains a current understanding of significant literature and methodology, as well as the scientific literature related to Vir Bio’s pipeline and R&D projects
• Works as part of a multidisciplinary team to bring discovery candidates into development and through licensure
• Generates literature reviews

WHO YOU ARE AND WHAT YOU BRING

• DVM or PhD in Pharmacology/Toxicology or Biomedical Sciences
• DABT Certification strongly preferred
• 12+ years of relevant experience in industry conducting biologics and pharmaceutical research and development, and preferably with oncology and infectious disease biologics specialization
• 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 to guide key nonclinical activities, setting up drug candidates for success at all stages of development
• Excellent scientific written and oral communication skills are required
• 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 with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures and disciplines