Primary Responsibilities will include, but not be limited to:

• Lead the development of clinical research plans, integration of the Clinical Development Plan (CDP) and Drug Development Plan, and development of Clinical Protocols.
• Drive the execution of clinical study from protocol concept to final resport, including the intepretation of clinical data.
• Act as the Medical Monitor for a study/clinical program, review and monitor study safety data.
• Serve as clinical/medical team expert to provide direction to all project team functions, organize Advisory Board meetings, and identify and liase with KOL regarding program strategy as well as scientific advice.
• Interpret study data and develop summaries for safety and efficacy.
• Reviews 3rd party (contractors, consultants and vendors) work product and deliverables to approve payment of invoices and resolves issues.
• Makes appropriate budgetary allocations to targeted opportunities.