We are seeking an Executive Director of Toxicology to join us in our mission to discover and develop drugs that improve human health through the use of breakthrough computational methods. We are seeking outstanding individuals to join our drug discovery group and contribute to our rapidly expanding portfolio of drug discovery programs and collaborations.
Our drug discovery and early clinical development team includes a cross-functional group of scientists and drug developers with experience working on all common target classes and therapeutic areas. The group is supported by more than 100 software developers and engineers as well as a large-scale compute infrastructure to apply our proprietary physics-based drug design and optimization platform. Ten of the programs we’ve worked on have progressed into preclinical development with four currently in clinic trials and one you’ll oversee nonclinical safety at all stages.
Who will love this job:
- A veteran toxicologist with cross therapeutic area and preclinical development experience across multiple advanced pipeline assets
- A preclinical development expert who can provide support and guidance, and can formulate project safety assessment strategies, with experience in discovery and IND-stage small molecule projects
- A highly-organized problem-solver who has excellent communication, presentation, and critical thinking skills
What you will do:
- Serve as the key resource and lead for toxicology, providing scientific knowledge and expertise to cross-functional project teams.
- Evaluate and identify areas for growth and/or team expansion in keeping with the portfolio growth and advancement
- Participate in multi-disciplinary team efforts and implement program-specific toxicology strategies to support compound and program progression
- Develop overall toxicology strategy and plans for lead candidates based on clinical development plans
- Address and resolve nonclinical safety issues arising in drug development and discovery programs (small molecules, biologics, novel formulations)
- Monitor outsourced GLP and non-GLP studies ensuring compliance with the protocol, any amendments, regulations, safety guidelines, a and standard operating procedures
- Write and review toxicology reports and documentation for regulatory filings
- Provide strategic recommendations on partnerships with non-clinical, translational and clinical CROs
- Engage with regulatory agencies, represent nonclinical safety at regulatory meetings and manage responses to queries from health authorities globally
What you should have:
- DVM or equivalent degree, or a PhD in toxicology or biomedical sciences or a related discipline with a minimum of ten years of industry experience preferred
- Experience managing and coordinating relationships with internal scientists, teams and external organizations, including regulatory health agencies
- Deep understanding of the drug development process across therapeutic areas (experience in the areas of Oncology and CNS preferred)
- A passion for working on diverse cross-functional teams as a functional area representative and communicating openly and often with colleagues
- An understanding of and experience with Good Laboratory Practices (US FDA 21 CFR Part 58)