Head of Toxicology
San Francisco, CA 94158 US
As a primary responsibility, this job has oversight for the design and execution of nonclinical safety programs to support the development of drug candidates from discovery to market authorization. The candidate will be highly motivated and manage a portfolio of small molecule projects utilizing proprietary targeting technology in Oncology and non-Oncology therapeutic areas. The candidate will work closely with non-clinical development colleagues to:
- Strategically plan and manage toxicology programs from target selection through GLP toxicology studies.
- Perform early safety assessments of therapeutic targets to identify potential safety concerns and develop strategies to address.
- Collaborate with strategic outsourcing partners, consultants, and regulatory toxicologists on design and execution of investigative toxicology studies in support of research and development compounds.
- As therapeutic candidates progress, interact closely with regulatory consultants to enable smooth progression of molecules into development and first in human (FIH) studies. Includes supporting authorship of candidate nomination documents as well as nonclinical reports.
- Communicate critical results, interpretation, and significant project information to various bodies including project teams and company leadership as required.
- PhD or equivalent degree from an accredited institution in the areas Toxicology or Pharmacology, with 7+ years related experience.
- A Veterinary degree with pathology training and/or DABT certification is also highly desirable.
- The candidate demonstrates a broad knowledge in field of toxicology and possesses practical knowledge of pharmaceutical toxicology including approaches to discovery toxicology, relevant regulatory guidelines, and preparation of submission documentation. Experience with IND, IB, NDA, & MAA submissions advantageous
- Demonstrates ability to work effectively in a cross-functional team environment.
- Excellent ability to communicate effectively both orally and in writing in an interdisciplinary environment.
- Salary range 230k-260k
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