Robert Morgan, JD, MS & BS.
Head Scientific Regulatory Legal Affairs & Quality
Mr. Robert Morgan is the Head Scientific Regulatory Legal Affairs & Quality at ESTERN Medical CRO Global Group. He has been one of the key members of ESTERN’S Corporate Scientific Advisory Board since April 2009. Mr. Morgan is a multi-faceted, hands-on, Senior Level Clinical and Regulatory professional with over 25 years’ experience in all areas of drug/device development covering the United States, Canada, Europe, Latin America, India, and Pacific Rim. He is the author of numerous successful INDs, CTA, 510(k), NDA, MAA, SPA, Orphan Drug and Pediatric submissions focusing on innovative treatments across multiple therapeutic areas, particularly Oncology. Mr. Morgan has an MS in Biophysics with practical clinical and research experience; JD with extensive experience in contract analysis and negotiation. He also filed the first electronic IND application accepted by the FDA in the new international standard Common Technical Document format.
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 senior executive positions in some of the top and most prestigious Medical Research and Clinical Regulatory Global Companies such as Samus Therapeutics, Medivector, ZIOPHARM Oncology, EPIX Pharmaceuticals, Inc, DuPont Pharmaceuticals Company, Genzyme Corp., Serono, PAREXEL International Corp. and Theseus Imaging Corp. He also curretly serves as the Senior Vice President Development Operations at Verastem Oncology.
He is also an Instructor in Regulatory, Quality & Drug Development as an Adjunct Faculty Member of The Healthcare Drug Development for the Graduate School of Engineering at Northeastern University in Boston, Massachusetts and a Faculty member for the European Regulatory Professional Society, TOPRA. With an educational scientific training background with BS and MS Science degrees and a Law Degree to harmonize his extensive expertise in legal contract analysis and negotiations.
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.