Chang Q. Lee, M.D., MSHA, Dr.PH, FCAP

Chang (Charlie) has combined experience of FDA medical reviewer, CMO/CRO and pharmaceutical industries for overall regulatory and clinical strategies in new drug development (of NCE, biological, generic, b(2), OTC and nutrition products), and leading clinical research/operation, statistical analysis, data management, medical and regulatory affairs. He is responsible for many clinical programs (Phase I – Phase IV global trial) in women’s health, anti-inflammatory, analgesics, CNS, anti-invectives, oncology and other therapeutic areas. For example, he led the clinical team to gain FDA approval on Mekana, the first drug approved in the US for reducing risk of preterm delivery and has extensive experience working with global regulatory authorities (USFDA, EMEA, MHRA, Health Canada, CDSCO (India), and CFDA (China)).

Work Experience

At Parexel, Chang is responsible for managing the consulting business in APAC to ensure growth of our presence and capabilities. Expanding the breadth and depth of our consulting services as well as providing biopharmaceutical companies outside of APAC with the recent regulatory reforms in China and the implications/opportunities to promote, collaborate and increase the profitability of consulting services in the region is also part of Chang’s charter.

Education

Chang received his M.D. from Xian Jiaotong University Medical College (formerly Xian Medical University) in Xian, China. Dr. Lee later went to the University of Alabama at Birmingham where he received his M.S. in Health Services Administration and then his Doctor of Public Health. Dr. Lee did his residency in Pathology at the University of Chicago, is Board-Certified in Clinical Pathology American Board of Pathology, and Fellow of American College
of Pathologist.