David Hopper Email & Phone Number

Experienced pharmaceutical development research scientist and laboratory animal veterinarian with 23 years working for large and small pharmaceutical companies and contract research organizations. Extensive experience in pharmaceutical program development, pharmaceutical development and risk/hazard assessment consulting, quality assurance, non-clinical organizational management, regulatory document preparation and submission, study designs, protocols, reports, summaries, IND’s and NDA’s. Areas of Expertise Include:• Management of non-clinical research operations• Study Director for many non-clinical studies with developmental drugs and medical devices• Project management for non-clinical small molecule and biologic drug programs• Experience guiding investigational drug projects to IND and NDA submissions• Management of Clinical Pathology, Safety/General Pharmacology, Culex Automated Blood Collection System, and Toxicology laboratories• Extensive non-clinical regulatory compliance and regulatory affairs experience with demonstrated success building GLP-compliant laboratories and successful FDA audits• Supervising veterinarian for animal research laboratories encompassing all common laboratory animals species, development of animal models, and innovations in research techniques

Listed skills include Toxicology, Drug Development, Cro, Pharmaceutical Industry, and 21 others.