Director, Project Physician - (Job Number: 0806159)

Director, Project Physician - (Job Number: 0806159) DescriptionJohnson and Johnson Pharmaceutical Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Director, Project Physician, located in Raritan, New Jersey. Johnson & Johnson Pharmaceutical 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. The Director, Project Physician 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 development program. The Project Physician provides active medical and scientific contribution to a cross-functional clinical team developing a new molecular entity currently being studied for metabolic applications. Team matrix interactions include project planning, regulatory affairs, data management, medical writing, biostatistics, worldwide medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology and other scientific and business related disciplines. The Project Physician may be asked to contribute to the evaluation of scientific opportunities in the metabolic area. The role requires a high-performing, and high-energy individual who demonstrates outstanding scientific and technical leadership, influence, the highest personal and ethical standards, and exceptional oral and written communication skills. Responsibilities and Expectations, in concert with staff, include: 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; May act as a medical contact at the 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 concert with senior clinical personnel, in preparation for FDA submissions; May act, in concert with senior clinical personnel, as a company spokesperson regarding publication of clinical research findings and presentations to relevant FDA advisory committees; 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 and may lead cross-functional teams for evaluation of new product ideas; implement franchise business strategies, etc.; Reviews medical literature and related new technologies; May be asked to assess external clinical research proposals involving company products relevant to company's mission; May be asked to assess medical publications emerging from the Team and its affiliates; May be responsible, with appropriate colleagues, for review of Company advertising and promotion; The Project Physician acts, in concert with medical staff, as a liaison between company and clinical investigators; The Project Physician develops, in concert with senior clinical staff, credible relationships with opinion leaders, medical directors, and key regulatory officials. Medical Doctor (MD) is required. Board Certified or Eligible in Internal Medicine or Endocrinology preferred. A minimum of 3 years pharmaceutical, CRO or biotech industry experience or equivalent experience in drug development in regulatory agency is required. Knowledge of clinical trial programs and the drug development process is required. Ability to travel up to 25% yearly required (International as well as Domestic). Energy and enthusiasm are essential. Outstanding oral and written communication skills (including report development) are required. Success working in a Matrix environment a strong plus. 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