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Director, Clinical Research Neuroscience

.  The Director Clinical Research is a responsible member of a clinical team dedicated to the development and execution of medical strategies and the clinical and operational implementation of a complex compound development program. The Director Clinical Research provides active medical and scientific contributions to a cross-functional clinical team developing and providing support for a neuroscience product. The Director Clinical Research provides input to the clinical development plan, works on the development of the clinical trial protocol(s), clinical trial materials, and takes ownership for the content of clinical study reports and relevant documents for regulatory filings. Team matrix interactions include project planning, project management, regulatory affairs, commercial, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations, market access, epidemiology and other scientific and business-related disciplines. The Director may be asked to contribute to the evaluation of business development opportunities within the Neuroscience therapeutic area.  The Essential Functions for the Director are: Responsible for medical monitoring/reporting and all clinical aspects of clinical trials; Works on clinical development plans, trial protocols and takes ownership of clinical study reports and other related documents; Evaluates adverse events (pre and post-marketing) for relationship to treatment; Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting; May act as a medical contact at the company for health authorities concerning clinical/medical issues. Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions. Experience in setup, design and analysis of clinical trial data is helpful.   Additional responsibilities include: Assists Regulatory Affairs in the development of regulatory strategies; Helps explore and evaluate new product ideas to assist in identifying new market opportunities; Support general Medical Affairs activities involving product evaluation, labeling and surveillance. Participate on and may lead cross-functional teams for evaluation of new product ideas, implement franchise business strategies, etc. Reviews medical literature and may be asked to assess medical publications emerging from the Team and its affiliates. Experience in presenting data at scientific meetings and a history of academic publications is helpful. The Director will report to the Clinical Leader and may be asked to manage one or more direct report(s) depending on workload. Qualifications MD (or equivalent) is required. Specialty training in Psychiatry with appropriate post-doctoral training and certification is preferred.  Other specialty training including neurology will be considered, depending upon experience. Additional degrees beyond the MD are preferred (PhD, Masters, etc). A minimum of 4 years of clinical trial experience (within the pharmaceutical industry, academia or CRO) is required. Excellent written and oral communication and presentation skills are a must.  A working knowledge of the use of Microsoft suite of software products including Excel and Word is required. Experience and knowledge of Good Clinical Practice and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings are required. Must have demonstrated the ability to work in a matrix organization with cross-functional teams. This position may require up to 10% annual travel (domestic and international). Requisition ID: 3999181009
Salary Range: NA
Minimum Qualification
5 - 7 years

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