Director Clinical Research (Oncology) - (Job Number: 0702117)

Director Clinical Research (Oncology) - (Job Number: 0702117) DescriptionCentocor Researchand Development, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director Clinical Research (Oncology), located in Chesterbrook, PA.Centocor Research and Development, develops innovative biomedicines. The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders.The Director Clinical Research is responsible for the development and execution of clinical programs for company products. Responsible for 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 officer 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 at company for the Food and Drug Administration and other worldwide health authorities concerning clinical/medical issues. Interprets, reports and prepares oral and written results of product research in preparation for FDA submissions. Assists 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. Creates clinical education and support programs. Helps 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. Reviews medical literature and related new technologies. Responsible for assessment of external clinical research proposals involving company products relevant to company's mission. A minimum of an MD is required. A Board Certified Oncologist with a minimum of 2 years clinical research & development experience in the pharmaceutical industry is preferred. A licensed physician with a minimum of 5 years oncology clinical research in the pharmaceutical industry will also be considered.Must possess Phase I-III clinical trial experience. Significant experience in supervising and managing clinical research programs and staff is required. Anticipated travel up to 25% domestic and international. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! Apply Now