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Senior Director of Medical Affairs
* Provide medical expertise to ongoing activities to support KALBITOR.
* Oversee the medical information/communications and medical science liaison teams.
* Provide medical input to documents including regulatory submissions, publications, medical information, medical education and advisory board presentations.
* Support the clinical development team as products move toward commercialization.
* Develop and manage staff as applicable including formal and informal mentoring and coaching.
* Strong people management skills; proven ability to develop people and build teams. Mentoring/Leadership ability.
* Ability to excel in an entrepreneurial environment; self-directed and comfortable with broad and varied job responsibilities. Comfortable functioning with ambiguity.
* Strong, adaptable communication skills with the ability to make complex ideas clear, simple, and understandable to a variety of internal and external audiences.
* Self-starter. Hand-on approach to projects. Flexibility.
* MD degree/Pharm D required.
* 5+ years of experience in the pharmaceutical industry.
* Strong clinical medical affairs background.
* Demonstrated ability to interact successfully with multiple functions, in particular research and development and commercial operations, and work effectively in a team environment.
* Excellent communication and presentation skills.
* Knowledge of FDA and other regulatory agency professional requirements, regulations and guidance.
* Ability to interpret clinical and efficacy data, including the strengths and weaknesses of study design and the applications of results to standard of care and clinical practice.
* 25% Travel requirements are variable and based on business need.
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