Director, Toxicology

Vir Biotechnology•San Francisco, CA

2d•Hybrid

About The Position

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.

Requirements

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

Responsibilities

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