Senior Leader in Toxicology and Safety

1 week ago


San Diego, California, United States Clinical Dynamix Full time
Job Summary

Clinical Dynamix is seeking a highly experienced and skilled Executive Director of Toxicology to lead our Toxicology team. As a key member of our Research and Development department, you will be responsible for overseeing and directing the activities of the Toxicology group, ensuring that toxicology studies are conducted in line with the appropriate guidelines and regulatory test standards.

Key Responsibilities
  • Provide strategic and operational direction to the Toxicology team, ensuring that all safety testing plans, registration activities, government submissions, and design control activities are addressed in accordance with Research and Development requirements.
  • Oversee and evaluate protocol preparation for toxicology studies, ensuring that all necessary steps are taken to ensure the success of the studies.
  • Collaborate with other Research and Development Team members and with Clinical Dynamix leadership to ensure safety pharmacology and toxicology support is provided to ensure provision of requisite data in a timely manner to meet development goals.
  • Critically evaluate toxicology results and provide timely strategic advice to project teams and senior management on the potential impact of toxicology results on Program and Clinical/Regulatory strategy.
  • Oversee and provide direction in the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.).
  • Represent Preclinical Development on discovery and development-stage program teams.
  • Develops critical insights from data summaries and shapes presentations of results to peers, colleagues, and Clinical Dynamix Management.
  • Oversee the adherence to all SOPs for Toxicology.
  • Proactively research and stay current on all applicable regulatory guidances.
Requirements
  • PhD in Toxicology, Pathology, or closely related discipline and 12+ years of pharmaceutical/biotech experience, including managing clinical Contract Research Organizations. Experience in toxicologic pathology is beneficial.
  • OR D.V.M and 8+ years of similar experience noted above.
  • Extensive previous leadership experiences also required.


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