Associate Medical Director/Medical Director, Endocrinology and Metabolism

The Associate Medical Director/Medical Director, will act as a key participant in the medical and scientific oversight of clinical studies in endocrinology and metabolism.

Responsibilities:

• Participate in the design, development and execution of clinical studies across the development life cycle (Phase1-3)
• Participate in the writing and review of clinical protocols, investigator brochures, clinical study reports, and other documents
• Provide medical oversight and safety monitoring for clinical trials including review of AEs and SAEs, and participation in the safety committee
• Play a key role in the analysis, interpretation and presentation of clinical data
• Work closely and collaboratively with other development functions, e.g. clinical operations, safety, biometrics, regulatory, medical writing, to achieve project objectives
• Establish relationships with external experts in the relevant scientific areas, including principal investigators and opinion leaders, to facilitate scientific excellence in clinical trials research
• Serve as liaison to the commercial team on medical and scientific issues
• Participate in appropriate regulatory discussion and activities, including the filing of IND’s, CTXs, and NDA/MAAs
• Provide ongoing disease area and scientific training to members of the clinical team
• Other duties as assigned

Preferred Skills, Qualifications and Technical Proficiencies: