Director, Clinical Research

The Director of Clinical Research will translate concepts/strategies into specific objectives and activities to effectively achieve goals. They will ensure appropriate scientific rigor in the design, conduct, validity and interpretation of clinical trials to support regulatory applications or business objectives. The candidate will contribute to the strategic planning, authoring as needed, and review of clinical and regulatory documents including protocols, CSRs, IBs, regulatory briefing packages or regulatory filing documents supporting BLA. They will also liaise with internal Clinical operations team and external partners as needed to ensure appropriate study execution and data collection. The role will contribute as the clinical point person to cross-functional teams including support of CMC activities, regulatory interactions and other business-critical needs. The person will contribute to the development and execution of publication plan to ensure strategic data disclosures aligned with company key messages and supported by clinical data.