Toxicology Director

1 day ago


San Diego, California, United States Clinical Dynamix Full time
Job Title: Executive Director, Toxicology

Clinical Dynamix is seeking an experienced Executive Director, Toxicology to lead our Toxicology team. As a key member of our Research and Development team, you will be responsible for overseeing and directing the activities of the Toxicology group.

Key Responsibilities:
  • Provide strategic and operational direction to ensure that toxicology studies are conducted in line with appropriate guidelines and regulatory test standards.
  • Oversee and evaluate protocol preparation for toxicology studies.
  • Ensure that all safety testing plans, registration activities, government submissions, and design control activities are addressed in accordance with Research and Development requirements.
  • Provide leadership, mentorship, and oversight to the Toxicology function in their conduct of all nonclinical safety assessments for our discovery and development compounds.
  • Drive the strategic vision and direction of the Toxicology function at Clinical Dynamix to enable development of world-class capabilities in support of numerous small molecule and biologic modalities.
  • Work in collaboration 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.
  • Represent Preclinical Development on discovery and development-stage program teams.
  • Develop critical insights from data summaries and shape 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.
  • OR D.V.M and 8+ years of similar experience.
  • Extensive previous leadership experiences also required.

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