Rolando Gutierrez-Esteinou
Dr. Gutierrez-Esteinou is a Harvard-trained psychiatrist and accomplished global clinical development executive, with more than 20 years of leadership experience advancing drug development programs in neuroscience and psychiatry.
His experience spans clinical development from Phase I through Phase IV across major neuropsychiatric disorders, including schizophrenia, mood disorders, addiction, and cognitive impairment. He has contributed to multiple late-stage development programs and regulatory submissions, including supplemental New Drug Applications (sNDAs) and label expansions for established CNS therapies such as Risperdal® (risperidone) and Abilify® (aripiprazole). He has led regulatory interactions with major global health authorities, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
More recently, Dr. Gutierrez-Esteinou served as Chief Medical Officer at Atai Life Sciences, where he oversaw a portfolio of clinical-stage CNS programs and built a multidisciplinary development organization supporting multiple trials across psychiatric indications. Throughout his career, he has held senior leadership roles across global pharmaceutical companies—including Johnson & Johnson, Bristol Myers Squibb, and Novartis—as well as in biotech and CRO environments.
Dr. Gutierrez-Esteinou completed his psychiatry residency at Harvard Medical School and held research fellowships at Harvard/McLean Hospital and the U.S. National Institutes of Health (NIH).
