Toxicology Director
3 weeks ago
We are seeking an experienced Toxicology Director to join our team at Clinical Dynamix, Inc.
Key Responsibilities- Provide strategic and operational direction to the Toxicology group, ensuring that toxicology studies are conducted in line with appropriate guidelines and regulatory test standards.
- Oversee and evaluate protocol preparation for toxicology studies, ensuring that all safety testing plans, registration activities, government submissions, and design control activities are addressed in accordance with Research and Development requirements.
- Responsible for in-life resource planning, maintaining current testing procedures, program development, performance monitoring, budget planning, and resource management.
- Provide leadership, mentorship, and oversight to the Toxicology function in their conduct of all nonclinical safety assessments for Company's discovery and development compounds.
- Drive the strategic vision and direction of the Toxicology function at Company 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 Company 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.
- Develop critical insights from data summaries and shape presentations of results to peers, colleagues, and Company Management.
- Oversee the adherence to all SOPs for Toxicology.
- Proactively research and stay current on all applicable regulatory guidances.
- 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.
- Demonstrated involvement in the preparation of INDs, CTAs, NDAs, and MAAs.
- Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of multiple scientific areas.
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