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Our client, an international pharmaceutical company located in northern New Jersey is in search of the following professional:
Director, Clinical Development- Neuroscience:
The Director of Clinical Development Neuroscience will be a member of Medical Affairs, involved in of multiple product development projects. He/she will provide neuro-therapeutic and pharmacovigilance expertise to the clinical development of the pipeline of neuro-therapeutic drugs with particular focus on epilepsy. He/she will also provide clinical operational support to each product development projects. The Director will work with regulatory, discovery, business development, legal, quality and CMC to facilitate the development products. The position will report to the Chief Medical Officer.
Participate in the development of product development plans and clinical trial strategy
Participate in the design and conduct of clinical trials and as a member of the Medical Affairs provide operational oversight by collaborating with internal and external operations personnel
Provide medical expertise regarding product development or other scientific issues for drug discovery and development, and senior management
Provide medical monitoring directly or oversee medical monitoring by vendors during the conduct of clinical trials
Participate in pharmacovigilance activities including SAE evaluation and reporting and analysis of safety data
Participate in preparation of protocols, Investigator Brochures, clinical study reports, safety reports, and the clinical sections of Annual Reports, INDs/IMPDs, NDAs/MAAs, SOPs, pediatric investigation plans, as well as abstracts and manuscripts
Interface with regulatory agencies for clinical development programs and regulatory submissions when necessary Oversee the scientific interaction with relevant medical consultants/ advisors and investigators
M.D. degree with specialized training in neurology/epilepsy preferred. Minimum of 3 years of experience in clinical development in the pharmaceutical industry, preferably with neurology compounds or relevant academic research experience.
Highly competitive base salary plus benefits and incentives.