Role:Principal Scientist, Toxicology
Location:South San Francisco, CA, US
- Function as project toxicologist to develop and design nonclinical toxicology program and strategies to advance early oncology targets into candidate selection and early clinical trials
- Design, direct, and monitor exploratory and GLP toxicity studies to support IND submission and/or advanced development stages
- Develop early nonclinical in vitro and in vivo safety screening assays and studies for de-risking strategies to help Discovery teams to progress early oncology targets into candidate selection stage
- Design and conduct hypothesis-driven investigative studies, or establish appropriate preclinical models, as needed, to better characterize the toxicity profile of the target and/or platform, and preclinical to clinical translational
- Design and conduct mechanistic studies to mitigate key toxicities associated with target and/or platformWork with toxicology study teams (internally or contract laboratory) on design, protocol development, and recommendation for appropriate end-points and study-related challenges
- Ensures timely and accurate communication of study results and interpretation to project teams
- Prepare verbal and written summaries and presentations of study results with interpretation for internal discussions and/or Drug Discovery/Development governing committees
- Develop and maintain collaboration across different functional teams to execute nonclinical plans for pipeline assets
- Ensure appropriate project management and oversight for multiple CROsMaintain a current understanding of small and large molecule translational science literature and methodology, as well as the scientific literature related to the specific drug discovery projects and/or tumor space
- Contribute to various regulatory documents and ensure regulatory compliance
- BasicPhD in Toxicology or other relevant field (such as DVM) with at least 8+ years of industry experience (or Bachelors/Masters with equivalent experience with 12 plus years of industry experience) as a study director/monitor in toxicology.
- Experience specifically supporting drug discovery research and development from a toxicology standpoint.
- Experience in designing, conducting, monitoring and interpreting nonclinical toxicology/research studies.
- Certification by the American Board of Toxicology (DABT) highly desired.
- Experience in oncology highly desired.Proficient at working independently as well as in cross-functional team settings.
- Excellent organizational and project management skills required for extensive interactions with multiple CROs and external study monitoring responsibilities.
- Working knowledge of GLP regulations, ICH, and other regulatory guidance documents, and experience conducting and monitoring toxicology studies is critical.
- Experience in designing, monitoring and interpreting nonclinical toxicology/research studies.Experience in writing nonclinical sections of regulatory documents.
- Strong working knowledge of MS office software, Adobe Acrobat Pro or equivalent.