Director - Clinical Research - Johnson & Johnson - Titusville

The Director Clinical Research will be responsible for the development and execution of clinical programs for a novel, new molecular biologic under development for the treatment of severe chronic pain. The Director will be responsible for: Assists in the development and execution of the overall clinical development strategy; Study design, protocol development and execution of clinical studies; Acts as a liaison between company and clinical investigators, develops credible relationships with opinion leaders, medical directors, and key regulatory officials; Responsible for medical monitoring/reporting and company safety activities;
Evaluates adverse events (pre and post-marketing) for relationship to treatment; Assists Regulatory Affairs in determining requirement for any corrective actions or health authority reporting. Acts as medical contact for the Food and Drug Administration and other health authorities concerning clinical/medical issues; Interprets, reports and prepares written and oral results of product research in preparation for regulatory submissions; and Supports general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance.

An MD/DO is preferred. Training in neurology is a plus; a PhD or PharmD will be considered with strong experience in drug analgesic development. This position requires a minimum of five years of clinical research and development experience. Experience in filing an NDA and experience in supervising and managing clinical research programs and staff is strongly preferred. At least two years of pharmaceutical industry experience is required. Will consider CRO or academically based experience with extensive involvement in clinical research and development. Ability to work in a matrix environment with cross-functional teams is required. Excellent oral, written and presentation skills are required. This position will require up to 20% domestic and international annual travel.

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