Clinical Research Medical Director, Rare Disease- Endocrine/ TE

View full description

Requirements:

• MD or DO degree from an accredited medical school
• 2 years of clinical research experience and/or basic science research
• MD plus accredited residency in relevant sub-specialty, board certified or equivalent. Endocrinology or ophthalmology training is preferred.
• Minimum of three (3) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities.
• Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical, or CRO company)
• Experience in lifecycle management of clinical development
• Key relationship development and collaboration with the expansive research, medical, and commercial teams – both internal and external
• Demonstrated ability to develop partnerships with key opinion leaders in the interest of medicine and science.

Responsibilities:

• Provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for the indication(s), primarily Thyroid Eye Disease (TED).
• Provide oversight of LCM clinical development with input on global strategy
• Medical monitoring for assigned clinical studies, including direct communication with Principal Investigators
• Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, research, and commercial access, and value input into the development program(s)
• Participate and provide clinical input into safety and regulatory interactions.
• Review, clean, interpret, and communicate clinical trial data.
• Author/review protocols, CSRs, publications, and regulatory submissions
• Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL.
• Identify new clinical research opportunities.
• Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization