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Director Clinical Research Immunology-5108120627
Janssen Research & Development LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for a Director of Clinical Research Immunology to be located in Spring House, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Director Clinical Research will be responsible for the development and execution of clinical programs within Rheumatology within the Immunology therapeutic area. The Director Clinical Research 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. Additionally the Director will identify and propose potential new research or development projects and assess the feasibility of pursuing these projects; represent the Immunology therapeutic area at presentations to corporate executive management, board of directors, corporate partners, regulatory agencies and the public 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. Support general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance.
This position will require a MD degree. Board certification or board eligible in Rheumatology is highly preferred. Experience in clinical research in academia or pharmaceutical industry required. 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 10% travel (domestic and international).
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Primary Location:North America-United States-Pennsylvania-Spring House
Organization: Janssen Research & Development, LLC. (6084)
Yes - Within Country
Travel:Yes, 10 % of the Time
Job Function: Clinical Research MD
Deadline: Monday, 5 August 2013