Robert Morgan, J.D., M.S. & B.S.
Head Scientific Regulatory Legal Affairs & Quality
Mr. Robert Morgan, is the Head Scientific Regulatory Legal Affairs & Quality at ESTERN Medical CRO Global Group. He is one of the key members of ESTERN’S Corporate Scientific Advisory Board since April 2009. Mr. Morgan also serves as the Senior Vice President, Regulatory Affairs, Quality, and Clinical Development and has served in that capacity since June 2006 at ZIOPHARM Oncology, Inc.
During his career he has submitted and maintained multiple IND, NDA and International regulatory filings and has been the team leader for multinational clinical studies. He also filed the first electronic IND application accepted by the FDA in the new international standard Common Technical Document format.
Mr. Morgan is a Multi-faceted, hands-on, senior level Clinical and Regulatory Executive, with over 25 years experience in all areas of drug development, in the United States, Canada, Europe, India, Pacific Rim and Latin America. Author of numerous successful IND, NDA and Orphan Drug submissions, specializing in innovative treatments across multiple therapeutic areas, particularly Oncology and Diagnostic Radiological Imaging .
His effectiveness, hands-on direction: design early phase clinical studies, draft regulatory submissions, including US and European Orphan Drug applications, draft abstracts and manuscripts for publication in professional journals. He also drafted proposed legislation on FDA Reform, including the drafting of background information for members of the US-Congress.
Mr. Morgan has held diverse executive positions in some of the top and most prestigious Medical Research and Clinical Regulatory Global Companies with EPIX Pharmaceuticals, Inc, DuPont Pharmaceuticals Company, Genzyme Corp., PAREXEL International Corp. and Theseus Imaging Corp. before joining ESTERN Medical CRO Group & ZIOPHARM Oncology, Inc.
He is also a Leading Instructor in Regulatory, Quality & Drug Development as a Adjunct Faculty Member of The Healthcare Drug Development for the Graduate School of Engineering at Northeastern University in Boston, Massachusetts. With an educational scientific training background with a Masters in Radiation Biophysics & Bachelors Science in Zoology and a Law Degree to harmonize his extensive expertise in legal contract analysis and negotiations.
Mr. Morgan received his Law Degree from the Massachusetts School of Law, and completed his Masters, in Radiation Biophysics at the University of Kansas City. He studied his BS in Zoology from the University of Massachusetts.
Mr. Robert Morgan has extensive publication track record and key member of diverse scientific organizations in the pharmaceutical industry; Member of the Massachusetts Bar Association, Food & Drug Law Institute, DIA & Regulatory Affairs Professional Society.