Seeking a Principal Scientist, Toxicology to contribute to the success of an exciting oncology pipeline. As a key team member, this role is responsible for setting nonclinical strategies, plan and execution of toxicology studies needed to progress discovery targets into early clinical trials and later development stages. This includes early safety de-risking strategies; design and conduct of exploratory and GLP toxicity studies; study directing/monitoring; data and report review; and contribution to regulatory submissions. The successful candidate will report to the Head of Toxicology group in South San Francisco, CA location.
- 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 platform
- Work 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 CROs
- Maintain 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
- PhD 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.
- Key Leadership Competencies:
- Builds strong relationships with peers and cross functionally with partners to enable higher performance.
- Demonstrated strong oral and written communication skills, teamwork, and attention to detail.
- Must have ability to rapidly adapt schedule to accommodate evolving project needs.
- Learns fast, grasps the "essence" and can change course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
- ·Embraces the ideas of others, nurtures innovation and manages innovation to reality.
- Strong interpersonal and communication skills with demonstrated ability to work within a team environment.
- U.S. citizen/green card holder