Associate Director, Clinical Research - Immunology - (Job Number: 0810262)

Associate Director, Clinical Research - Immunology - (Job Number: 0810262) DescriptionJohnson && Johnson Pharmaceutical Research && Development, L.L.C., La Jolla, develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, metabolic disorders, inflammation disorders and pain.As the Associate Director Clinical Research you are responsible for the development and execution of clinical programs for new chemical entities encompassing study design, protocol development and execution of clinical studies. Act as a liaison between company and clinical investigators. Develop credible relationships with opinion leaders, medical directors, and key regulatory officials in the relevant therapeutic area. Responsible either directly or in collaboration with assigned MD for medical monitoring/reporting and company safety officer activities. Evaluate adverse events (pre and post-marketing) for relationship to treatment. Assist Regulatory Affairs in determining requirement for any corrective actions or health authority reporting. Act as medical contact at company for the Food and Drug Administration and other worldwide health authorities concerning clinical/medical issues. Interpret, report and prepare oral and written results of product research in preparation for FDA submissions. Assist Regulatory Affairs in the development of drug/device regulatory strategies. Acts as company spokesperson regarding publication of clinical research findings and presentations to relevant FDA advisory committees. Create clinical education and support programs. Help explore and evaluate new product ideas to assist in identifying new marketing opportunities. Support general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance. Participate on cross-functional teams for evaluation of new product ideas, implement franchise business strategies, etc. Review medical literature and related new technologies. Responsible for assessment of external clinical research proposals involving company products relevant to company's mission. The successful candidate will have an MD degree.This position also requires a minimum of 5 years of clinical and or research experience. A minimum of 2 years of industry experience, including clinical research and clinical study experience, is strongly preferred. Immunologic/Rheumatologic expertise is highly desirable. Approximately 15% - 20% domestic and international travel is required. Apply Now