Our start-up client is building their scientific leadership team and seeking an experienced Toxicologist to join them! In this role, you will lead the development and execution of the toxicology profiling of the companies drug candidates, including risk assessment /mitigation, and development of innovative toxicology strategies.
Key Responsibilities
Lead nonclinical toxicology for the companies small molecule portfolio across preclinical and clinical development.
Formulate toxicology strategies to advance programs.
Represent nonclinical toxicology on project teams and interface with internal stakeholders in discovery and development, as well as interface with regulatory agencies.
Oversee the design and conduct of outsourced toxicology and safety pharmacology studies.
Analyze and interpret nonclinical toxicology and safety data; summarize and communicate findings, as well as provide guidance on follow-up/mitigation strategies.
Spearhead investigative efforts to elucidate mechanism of toxicity as needed.
Manage collaborations with CROs and consultants to support non-GLP and GLP studies.
Author regulatory documents including contributions to IND, CTA, BLA, NDA, IB, as well as contribute to communications with regulatory agencies.
Participate in the preparation of posters, abstracts, and manuscripts for publication.
Qualifications
A MS or PhD in Toxicology, Pharmacology, or other relevant field with minimum 12-15+ years of drug discovery and development experience in toxicology
Certified Diplomate of the American Board of Toxicology preferred.