Proven track record with over 25 years in pharmaceutical development industry, and experience from both sponsor and service provider sides. Prior to industry gained pre-clinical research experience working in an academic setting. Experience in strategic development and operational management of clinical programs being conducted for regulatory approval; leading multidisciplinary international teams from pre-clinical proof of concept through full clinical development stages to final reporting and Regulatory submissions, on to market in the US and Europe. Participation as an Advisor on Clinical and Scientific Advisory Boards, and currently provide clinical consulting (strategic and operational) and clinical quality compliance services to pharmaceutical, biotechnology and device companies. Proven track record of excellence in organizational ability; Leadership skills, working with all staff levels; ability to support team growth and development objectives; Highly developed communication and interpersonal skills to facilitate liaison with external collaborators including Key Opinion Leaders, Regulatory Authorities, commercial development groups and co-licensees.