Thirty (30) years of clinical research experience in the life science industry, including cross-functional leadership in biopharmaceutical drug development from IND-enabling studies through filing of new drug applications (NDAs).  Strategic planning of all phases of clinical trials, including resourcing and oversight/execution to achieve program objectives and high quality deliverables within established time lines and budgets.  Ensure operational excellence in clinical stage programs by applying high industry standards, policies, systems, and processes across all trials. Medical writing of clinical study protocols, case report forms, patient consent forms, IND Annual Reports, IBs, CSRs, and other clinical documents for submission to regulatory agencies and review boards.