FDA Officer, Clinical Research Methodology, Regulatory Compliance  and Medical Policy Development, Center for Drug Evaluation and Research, FDA

Dr. Rodriguez-Chavez serves as an FDA Officer for Clinical Research Methodology, Regulatory Compliance and Medical Policy Development at CDER.  He is a biomedical leader with expertise in Virology, Microbiology, Immunology, Vaccinology, and Oncology. Overall, he has over 20 years of work experience at NIH, industry and non-profit research organizations.  Past positions he has held include: CEO and Founder of a biomedical consulting firm, 4Biosolutions Consulting, Rockville, MD; Vice-President for Research at the Texas Biomedical Research Institute, San Antonio, TX; Director of the AIDS and Immunosuppression Program at NIDCR, NIH, Bethesda, MD; Senior Clinical Scientist at Schering Plough Corporation, Kenilworth, NJ; and Director of Portfolio for HIV Vaccine Programs at NIAID, NIH, Bethesda, MD.  Dr. Rodriguez-Chavez has expertise in science and technology, pre-clinical and clinical research, development and operations, regulatory affairs, approval or licensure of medical products, and quality control and quality assurance. He has led basic, translational, pre-clinical and clinical research (phase I – IV global trials). He has issued the first U.S. GCLP Guidelines and published numerous scientific and technical articles. He has a B.S. in Biology (Venezuela), M.S. in Microbiology (Venezuela), M.H.S. in Clinical Research (Duke School of Medicine), and a Ph.D. in Virology and Immunology (University of Delaware). 

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