Senior CNS Medical Director, NC, USA – North Carolina, USA
The Senior CNS Medical Director of this pharmaceutical company will be responsible for providing medical/scientific input and expertise to: Ensure the medical/scientific coherence and quality of clinical development programs conducted in epilepsy. Contribute to the generation of the Clinical Development Plan leading to successful registration and launch of new chemical entity/new biological entity and additional approvals of new line extensions of registered compounds. They will contribute to the design, conduct, and interpretation of specific clinical trials, specifically their relevance for the target disease and drug candidate. Ensure the study-related safety of the subjects in the clinical trials through appropriate medical monitoring of studies on an ongoing basis. Collaborate with relevant company departments in order to follow-up the operational implementation of assigned trials or clinical development programs. Establish/maintain credibility of the Global Therapeutic Area while interacting with other internal departments and external experts. Contribute to the clinical section of documents including, but not limited to the Investigator Brochure, Annual IND Safety Updates/European Annual Reports, Clinical Study Reports, and submission related documents such as the Clinical Summary of Efficacy and Safety and the Clinical Overview. In addition, the translation of Medico-scientific innovation for corporate projects, and promote scientific innovation in collaboration with Research and Experimental Medicine.
REQUIREMENTS: The Senior CNS Medical Director must have a 'minimum' of 5 years of experience in academia and/or the pharmaceutical industry, substantiated by a relevant scope of publications for individual medico-scientific bench-marking. In addition, a highly-respected individual considered a medical/scientific expert (e.g. KOL) in epilepsy. Board certified in neurology. Experience in writing and filing files (including safety updates) and of all aspects of the clinical development process, preferred.
302 East 49 Street
New York, New York 10017
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