Provides leadership and therapeutic expertise for the successful management of international clinical trials. Participates in development of SOPs, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory, safety documents. Contributes to development of abstracts, presentations, and manuscripts. Contributes to the strategic implementation of a clinical development program(s). Provides input into the management of the Clinical Trials Management department. Recruit, hire, mentor, and manage CPA/CRA/CPA direct reports and support their professional development.