Robert Levin, MD

Dr. Robert Levin is a seasoned physician and regulatory expert with nearly two decades of experience at the U.S. Food and Drug Administration (FDA). During his tenure, he held leadership roles across the Office of New Drugs and the Office of Safety & Epidemiology, including serving as Lead Medical Officer in the Division of Psychiatry Products and Director in the Division of Pharmacovigilance. He specialized in evaluating psychiatric drug development programs, overseeing clinical review, pharmacovigilance strategy, and risk-benefit analyses from pre-IND through post-marketing phases.

Following his FDA career, Dr. Levin founded LevIntel Consulting, where he provides guidance on regulatory and medical affairs, clinical drug development, safety and pharmacovigilance, Risk Evaluation and Mitigation Strategies (REMS), real-world evidence and data (RWE/RWD), and the application of AI in healthcare. His expertise spans multidisciplinary collaboration, clinical trial protocol development, and regulatory decision-making, supporting clients in navigating complex scientific and policy challenges.

Dr. Levin earned his Doctor of Medicine from Yale University School of Medicine and completed his residency in General Psychiatry at the University of Pittsburgh Medical Center. He has also contributed to academia and research as an Assistant Professor of Psychiatry, and as a clinical researcher at the National Institutes of Health, focusing on neuropsychiatric and Alzheimer’s disease studies. Known for his strategic insight, analytical rigor, and collaborative leadership, Dr. Levin continues to advance safe and effective drug development through consulting and advisory roles.

• Yale University School of Medicine - Doctor of Medicine - MD
• University of Pittsburgh School of Medicine - Residency in General Psychiatry
• Tufts University - Bachelor of Arts - BA, Philosophy and Pre-Medical Sciences

• American Board of Psychiatry and Neurology