Bruce Smith, PharmD
Executive Director, Clinical Operations
bruce.smith@unitedbiosource.com
Dr. Smith is Executive Director, Clinical Operations at United Biosource Corporation (UBC), where he is responsible for the supervision of the project management, medical monitoring, safety surveillance, site monitoring and site management groups in multiple UBC locations. The primary focus of his clinical operational activities is in the conduct of large simplified trials, post-marketing surveillance programs (particularly regulatory agency required programs), treatment INDs and well controlled peri-approval and post-approval programs. He is directly involved in the evaluation of client requests for proposal, ensuring that tailored operational solutions are developed for each program, transitioning awarded programs into implementation and monitoring the progress of studies through direct participation in the service delivery chain.
Dr. Smith has 27 years of combined clinical, research, and management experience with 18 years in the contract research organization environment. He has been involved in clinical research on more than 50 of the top 200 prescribed drugs in the United States and more than 40 anti-infective compounds. Dr. Smith was a faculty member in the Department of Medicine, Division of Infectious Disease at Hahnemann University (now Drexel University) School of Medicine and then a member of a private Internal Medicine/Infectious Disease Practice. In both environments he was active in conducting both clinical and laboratory based research. He authored or co-authored over 100 journal articles, book chapters and abstracts in the field of Infectious Disease in such representative refereed journals as Archives of Internal Medicine, American Journal of Medicine, Chest, Orthopedics, Antimicrobial Agents and Chemotherapy, Journal of Antimicrobial Chemotherapy and Medical Clinics of North America. In these roles, he was active in the microbiology and pharmacy societies and chaired sessions at national meetings, has been guest lecturer at numerous medical and pharmacy society meetings and consultant to various pharmaceutical companies.
Prior to joining UBC, Dr Smith entered the CRO industry in project management with PACT and subsequently, Corning-PACT and Covance. He assumed increasing levels of responsibility within these organizations culminating in becoming Vice President, Clinical Operations in the peri-approval services group. He was responsible for project management, medical monitoring, site monitoring, site management, safety surveillance, biostatistics and medical writing services, involving over 300 staff globally. Dr. Smith traveled extensively in resource poor environments developing relationships with regulatory authorities, health care providers and support groups. He was instrumental in development of stand alone safety services, in-sourcing of staff to clients, establishing global peri-approval offices and responding to federal contract solicitations.
