Senior Director Nonclinical Development

Role: Senior Director of Nonclinical Development responsible for overseeing all aspects of preclinical pharmacology and toxicology for pharmaceutical products. Objectives include directing staff, developing regulatory strategies, designing experiments, interpreting data, and ensuring quality in nonclinical studies. Responsibilities encompass managing study protocols and reports, communicating findings to internal teams and regulators, and representing the company in regulatory meetings. Qualifications: Bachelor's degree with 15+ years of experience, ideally with a DVM, PhD, or PharmD in biomedical disciplines; expert knowledge of drug development requirements for regulatory submissions; extensive experience with GMP, GLP, GCP, and global regulatory processes. Preferred skills include strong leadership, communication, and technical expertise in pharmacology and toxicology, with the ability to provide guidance across R&D, regulatory, and business teams. High-Value: Focus on pharmaceuticals with a need for robust nonclinical data for IND/NDA submissions, regulatory agency interactions, and risk assessments. Work setup is primarily office-based with occasional travel; supervisory responsibilities are included. The role demands strategic thinking, scientific proficiency, and proven ability to interface with regulatory bodies and cross-functional teams.