Over 35 years of experience in the pharmaceutical industry, most recently as a manager in late phase clinical development in the infectious diseases therapeutic area. Specific activities include:- Scientific Manager providing clinical microbiology expertise and support to late phase clinical programs- Serve as Clinical Investigation Leader or Operations & Scientific Leader for Phase II/III/IV global clinical trials in infectious diseases, with emphasis in anti-bacterials and anti-malarials- Review, prepare or assist in the preparation of clinical documents for worldwide submissions - Develop and assist in development of protocols, case report forms, electronic data entry systems, informed consent forms and clinical study reports- Conduct study feasibility plans and investigator recruitment- Responsible for review of statistical analysis plans, output specification documents and data validation specifications through interaction with Statistics and Clinical Data Management personnel- Review and approve study budgets and contracts- Interact with contract research organizations and advise on study-related medical issues- Author manuscripts for external publication- Review investigator manuscripts and abstracts in preparation for external publication- Prepare documents for FDA Advisory Committee Meetings- Participate in local and national Advisory Board Meetings