Clinical Leader - Psychiatry Franchise - (Job Number: 0809930)

Clinical Leader - Psychiatry Franchise - (Job Number: 0809930) DescriptionJohnson and Johnson Pharmaceutical Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Clinical Leader Psychiatry Franchise, located in Titusville, NJ. 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 Clinical Leader (CL) is responsible for the development and execution of medical and scientific psychiatric strategy, and its operational implementation, delivered through the effective leadership of a cross-functional Clinical Team (CT). The CT is charged with advancing a selected molecular entity to successful global registration for psychiatric indications. The CL leads the team to develop products in a timely and cost effective manner, and is responsible for study design, protocol development, and execution of clinical studies. The CL will manage direct reports who are CT physicians. Team leadership via matrix interactions also includes individuals from project planning, project direction, regulatory affairs, data management, medical writing, biostatistics, drug safety and benefit-risk management, pharmacogenomics, drug discovery, early clinical development, experimental medicine, clinical pharmacology, clinical operations, health economics, epidemiology, worldwide medical affairs and other scientific and business related disciplines. The CL is also expected to assist in the leadership of the evaluation of scientific opportunities in the CNS area. The role requires a high-performing, high-energy individual who demonstrates outstanding scientific and technical leadership. He/she will also demonstrate the ability to influence strategy in a matrix environment, possess exceptional oral and written communication skills, have proven ability in personnel development and exhibit the highest personal and ethical standards consistent with the tenets of the J&&J Credo. The CL assumes an important role on the multi-functional Compound Development Team (CDT), representing Clinical Development, as well as Clinical Operations, Data Management, Biometrics and Biostatistics, Benefit-Risk Management and other disciplines. The CL will report directly to the Franchise Medical Leader - Psychiatry. Responsibilities and Expectations, in concert with staff, include: Recruitment, supervision, and development of junior medical staff; Interprets, reports and prepares results of product research in preparation for world-wide health authority and FDA submissions; Responsible for medical monitoring/reporting and 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 worldwide health authorities concerning clinical/medical issues; Assists Regulatory Affairs in the development of drug/device regulatory strategies; May act as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committees; Helps explore and evaluate new product ideas to assist in identifying new marketing opportunities; Supports general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance; Supports early clinical development and discovery activities involving product potential and development for registration; Participates on and leads 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; Responsible for assessment of medical publications emerging from the Team and its affiliates; Responsible, with appropriate colleagues, for review of Company advertising and promotion; Acts as a liaison between company and clinical investigators; Develops credible relationships with opinion leaders, medical directors, and key regulatory officials. A MD (or international equivalent medical degree), or a Ph.D. in a relevant licensed clinical discipline, is required. Board Certification or Eligibility in Psychiatry is strongly preferred. Additional education, such as a PhD in a neuroscience specialty area, and significant academic or pre-clinical CNS research experience is especially desirable. Energy and enthusiasm are essential. Exceptional written and oral presention skills are required. A minimum of 5 years of highly successful managerial/supervisory, including team leadership roles, experience is an asset. A minimum of 5 years Drug Development experience is required as well as a minimum of 3 years pharmaceutical industry experience. Also required is CNS experience as well as Phase II/III experience. Global Drug Development experience strongly preferred. Worldwide registration experience strongly preferred. Experience working or interacting with the FDA is very strongly preferred. Expertise in clinical drug development including demonstrated ability to develop clinical development plans meeting the highest standards is required. Ability to interface effectively with discovery, preclinical, and marketing is required. Experience working in a Matrix environment is required. Up to 15-20% yearly travel is required (International as well as Domestic). 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