VP Toxicology

The VP, Toxicology leads the development and execution of the toxicology profiling of the companies drug candidates, including risk assessment /mitigation, development of innovative toxicology strategies, and communication of plans throughout the organization to ensure cross-functional alignment. 

Key Responsibilities

  • Lead nonclinical toxicology for the companies small molecule portfolio across preclinical and clinical development.
  • Formulate toxicology strategies to integrate with the companies teams 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.
  • Review and edit draft study reports and ensure timely finalization.
  • Author high quality 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.
  • Perform all duties in keeping with the companies values, policies, and all applicable regulations.

Qualifications

  • PhD in Toxicology, Biology, Pharmacology, or other relevant field with minimum 12 years of professional/industry experience in toxicology-related research and/or drug discovery and development.
  • Certified Diplomate of the American Board of Toxicology preferred.