The Director/Sr. Director of Clinical Development will report directly to the VP of Clinical Development and will be responsible for implementing and directing the clinical strategy of the development programs. The successful candidate will possess a solid understanding of US and international regulations and the drug approval process. A clear understanding of translational medicine is required, including but not limited to, basic pharmacokinetics/pharmacodynamics principles, the use of biomarkers, and data interpretation as they apply to drug development. This role will manage the design and execution of clinical studies, oversight and interpretation of clinical trial data and clinical interactions with cross-functional groups across the organization. This role will also include external interactions with regulatory authorities, key opinion leaders (KOL), scientific and academic collaborators, patient advocacy organizations, and other external stakeholders.
Competencies and Attributes: