An experienced professional who engages effectively at the highest levels of the Pharmaceutical Industry, Government, the Medical Profession and Academia. A strong and effective leader providing strategic direction and inspiration whilst achieving results through teamwork and empowerment. Has brought more than 20 new commercially successful drugs to the market and has worked with over 250 New Chemical Entities [NCEs]. Extensive experience of working with E.U., U.S. and Japanese regulators and health care professionals. Possesses in-depth knowledge of drug development from research through Phase 1-3, Phase 4 and line extensions/new indications. He has managed clinical and preclinical programmes to proof of mechanism and proof of concept. Established development and medical functions including quality systems, 21CFR11 compliant document management system and GCP compliant outsourcing practices.