Director, Clinical Development CV Franchise - (Job Number: 0806084)

Director, Clinical Development CV Franchise - (Job Number: 0806084) DescriptionOrtho-McNeil Janssen Scientific Affairs, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Director, Clinical Development CV Franchise, located in Raritan, New Jersey. Ortho-McNeil Janssen Scientific Affairs, L.L.C. is dedicated to providing medical information and consultative support to a number of J&J's pharmaceutical companies. The company's mission is to create the pre-eminent model of scientific excellence in the promotion of public health. The Director, Clinical Development CV Franchise provides oversight and direction as required for the design, conduct and analysis of clinical trials. Specific activities include study design, protocol development, fulfilling the role of medical monitor and ensuring study conduct is in compliance with GCPs and applicable SOPs, directing appropriate analyses and preparing final reports, and partnering with regulatory affairs as required for filing of FDA documents. Provides clinical and scientific leadership through interaction with internal and external experts, partners with colleagues across Medical Affairs, JJPRD, Brand Marketing, Regulatory Affairs, PGSM, New Business Development, J&J Corporate Communications, and J&J Legal. Frequently interacts with Field- based Scientific Affairs, participates in promotional copy review and supports medical information services. Develops and fosters relationships with thought leaders, scientific societies and advocacy groups. Remains current with and contributes to the scientific literature within field of focus. Participates in the development of scientific and communication plans and reviews manuscripts for scientific accuracy and fair balance. Guides the process of post-hoc exploratory analyses and communication of the results. Participates in the decision to fund investigator initiated studies and provides clinical support as required. Responsible for leading a team of one or more Associate Directors, Managers, and/or personnel allocated to the franchise. Interacts with CROs, external agencies and contract personnel as required. Contributes to L&A activities as called upon and continually seeks new compound opportunities. MD with 6-8 years of post-doctoral experience (clinical, academic and/or pharmaceutical) of which at least 1-2 years have been in the pharmaceutical industry is required. Extensive knowledge of trial design, statistical methods, data analysis and medical writing is required. Cardiovascular experience is required with thrombosis experience preferred. Demonstrated conformance with GCP and ICH guidelines and ability to manage budgets across multiple studies are preferred. Record of publication in peer-reviewed medical journals and contribution to professional society or advocacy group are required. Experience contributing to the development of scientific and business plans is an asset. Effective interpersonal, presentation and written communication skills. Excellence in planning, organization and prioritization. Ability to identify key business needs and respond appropriately; ability to lead an internal team in the design and execution of programs responsive to those needs; extensive knowledge of industry specific medical and legal regulations, procedures and practices relevant to clinical research, publication and promotional activities. This position will require from 20-25% travel (primarily domestic with some 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