Vir Biotechnology (Vir), a San Francisco based company focused on infectious diseases seeks a Director of Toxicology. As the Director of Toxicology, you will be primarily accountable for nonclinical toxicology, and will be an integral member of nonclinical and clinical teams driving the overall global nonclinical regulatory submission strategy and coordination of multiple Vir portfolio products, from research to registration and beyond. The successful candidate has experience in evaluating and responding to inquiries from regulatory authorities tackling global nonclinical development issues in support of IND and NDA/BLA packages. You will represent the department at the project team level and directs nonclinical development activities to ensure timely high-quality project deliverables.
- Excellent management capabilities and is a critical part of an innovative team supporting the company’s drug development goals.
- Conceptualizes and designs toxicology studies to support research and development programs.
- Manage and monitor nonclinical studies (GLP and non-GLP) at the CROs per Vir’s vendor management SOPs.
- Critically reviews and interprets nonclinical toxicology study reports and coordinates report finalization. Ensures documentation is consistent with the necessary global regulatory and compliance requirements.
- Familiarity with GLP regulations and regulatory guidelines for testing biopharmaceutical and small molecules is required.
- Contributes to, prepares and reviews regulatory documents (CTAs, IMPDs, INDs, BLAs, etc) and interacts with regulatory authorities as needed.
- Provides leadership and participation on cross functional teams as nonclinical development SME to confirm proper integration of nonclinical activities into overall project plans.
- Partner with and provide subject matter expertise to key internal stakeholders (e.g. Regulatory, Clinical, CMC) and their external co-collaborators.
- Contribute to the departmental procedures such as SOPs and templates.
- Maintain a current understating of significant literature and methodology, as well as the scientific literature related to the specific Vir pipeline projects and R&D projects.
- Works as part of a multidisciplinary team to bring discovery candidates into development.
- Willing to engage in non-toxicology projects, assisting with infectious diseases pre-clinical (in vitro and in vivo experiments) and clinical (i.e., engaging CROs, reviewing pathogen endpoints assays, help with immunological data acquisition).
- Generates literature reviews.
QUALIFICATIONS AND EXPERIENCE:
- 10+ years of relevant experience in industry conducting biologics and pharmaceutical research and development, and preferably with infectious disease biologics specialization.
- IND experience is required, BLA or NDA experience desired.
- Strong knowledge of FDA, EMA, and ICH guidances including GLP regulations.
- Experience in authoring regulatory submissions, including full BLA/NDAs or significant sNDAs (desired), as well as multiple INDs (required) and preparing science-based responses to regulatory inquiries.
- Deep understanding of QA, regulatory, and clinical functions 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.
- Proven ability to work highly effectively with multiple departments.
- 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.
- DVM or PhD in Pharmacology/Toxicology or Biomedical Sciences.
- Diplomate of the American Board of Toxicology preferred.