BIO
Bernardo Haddock Lobo Goulart, M.D.
Vice President - Technical, Regulatory Strategy
BIO
Vice President - Technical, Regulatory Strategy
Dr. Goulart is an experienced Medical Oncologist and Clinical Researcher with over 17 years of expertise in drug development, regulatory science, and oncology practice, including roles at the FDA and academic medical centers. With many years as a practicing thoracic oncologist and investigator, Dr. Goulart combines clinical experience with research skills, including leadership in HEOR and real-world studies, while being recognized for his critical thinking, team engagement, and patient-centered approach.
Work Experience
During 4+ years as a Medical Officer at the FDA, dr. Goulart has reviewed numerous INDs, expedited program designations, and NDAs/BLAs, while also representing the FDA in multiple meetings with pharmaceutical companies and at Oncology Drugs Advisory Committee meetings. He has continuously served as Principal Investigator or Co-Investigator on various industry-sponsored and investigator-initiated clinical trials in thoracic oncology and Head & Neck Cancers. Additionally, Dr. Goulart has led multiple HEOR and RWD studies applied to oncology, cancer care delivery, and comparative effectiveness.
Education
Dr. Goulart first obtained his Doctor of Medicine degree from Universidade Federal do Rio de Janeiro (Brazil, 1997) and progressed his education with Master of Science in Pharmacoeconomics and Outcomes Research from the University of Washington School of Pharmacy (USA, 2010). Finally, he has supplemented the wide clinical practice with the Medical Oncology Fellowship at the University of Washington/Fred Hutchinson Cancer Center (USA, 2007-2011).