Dr. Lei Zhang has over25 years of experience spanning across the biotech/biopharma, medical device, diagnostic, and CRO industries. Her unique drug development lifecycle expertise includes global clinical development & operations, scientific innovation, and regulatory interactions with the FDA (CDER, CBER, CDRH). Dr. Zhang engaged various therapeutic indications in oncology, cardiology, endocrinology, dermatology, OB/GYN, gastroenterology, urology, and infectious diseases. Her track record includes contributions to development strategy, corporate partnership, clinical trial design and execution (Phase I-III, 510(k), PMA) as well as regulatory submissions. Lei provides leadership overseeing functional teams in clinical/regulatory affairs, program management, Biostat, data management, medical writing, CRO/vender selection.
Dr. Zhang received her M.S. from Beijing Medical Univ. and Ph.D from Germany; performed postdoc research at MIT. Lei is an active speaker at biotech & biopharma forums on clinical/regulatory topics.