Overall strategic management for the planning, execution and reporting of multiple clinical programs (phases I - III) needed to support INDs, SNDAs, NDAs with focus on execution, administration and organization. Provide input to protocols in cooperation with medical staff and statistics group. Set project goals, develop feasibility assessments to plan for accurate number of qualified investigators for study conduct to support clinical development plans. Oversee Clinical Operations Managers and assure adherence to high quality GCP/ICH standards for studies.