Clinical Dynamix, Inc.
Executive Director, Toxicology
Clinical Dynamix, Inc., San Diego, California, United States, 92199
Do you have a Toxicology background and strong Leadership? Our Publicly Traded Client is expanding. Looking for an Executive Director, Toxicology with strong Leadership experience. Company is based in San Diego and does require on-site presence. Robust compensation package offered including full relocation and other Long Term Incentives.
Oversees and directs the activities of the Toxicology group. Provides strategic and operational direction ensuring that toxicology studies are conducted in line with the appropriate guidelines and regulatory test standards (FDA, WHO, GLP, and ISO). Oversees and evaluates protocol preparation for toxicology studies. Ensures 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.
Essential Functions
Provides leadership, mentorship, and oversight to the Toxicology function in their conduct of all nonclinical safety assessments for Companys discovery and development compounds
Drives 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
Works 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 provides 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 Company Management.
Oversees the adherence to all SOPs for Toxicology.
Proactively research and stay current on all applicable regulatory guidances
Other duties as assigned
Knowledge and Qualifications
Common Knowledge & Skills:
Oversees and directs the activities of the Toxicology group. Provides strategic and operational direction ensuring that toxicology studies are conducted in line with the appropriate guidelines and regulatory test standards (FDA, WHO, GLP, and ISO). Oversees and evaluates protocol preparation for toxicology studies. Ensures 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.
Essential Functions
Provides leadership, mentorship, and oversight to the Toxicology function in their conduct of all nonclinical safety assessments for Companys discovery and development compounds
Drives 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
Works 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 provides 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 Company Management.
Oversees the adherence to all SOPs for Toxicology.
Proactively research and stay current on all applicable regulatory guidances
Other duties as assigned
Knowledge and Qualifications
Common Knowledge & Skills: