Clinical Development Program Director - (Durham, NC)

The Clinical Program Director is accountable for clinical strategy and leading the development and execution of a component of the clinical development program, which may include but is not limited to: • Responsible for planning, designing, defending, and ensuring implementation of the Clinical Development Plan (CDP) and Pediatric Investigational Plan (PIP) enabling successful regulatory filings, approvals, and launches of NCEs/NBEs and additional approvals of new line extensions (indications or formulations) of registered compounds. • Prompt identification of emerging efficacy or safety data that warrant re-evaluation of project plan and/or potential termination prior to registration. • Develops and maintains excellent working relationships and collaboration between the Patient Value Unit (PVU) and Practice to ensure broad high-quality medical, scientific, regulatory, commercial and external input into the clinical programs.