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.

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

Common Knowledge & Skills:

Clinical Dynamix, Inc.