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New Brunswick, NJ, US

Sr. Director, Epidemiology, Medical Devices & Diagnostics-0484130115

Description

Johnson & Johnson is recruiting for a Sr. Director, Medical Devices & Diagnostics. This position is located in New Brunswick, NJ.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

With $65 billion in 2011 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 118,000 people in 60 countries throughout the world.

The Medical Device & Diagnostics Safety & Surveillance Center of Excellence is seeking a Senior Director, Epidemiology to provide research support to Medical Device & Diagnostics (MD&D) franchises/Operating Company's and drive medical safety and surveillance of MD&D products. This position reports to the Chief Medical Officer for MD&D.

The primary responsibilities of the Sr. Director, Epidemiology will be to provide thought leadership in epidemiology and post-market surveillance, this will include exploring external electronic, patient-level database(s) (Administrative Claims/EMR/Surveys/Registries etc) to evaluate disease natural history, clinical and surrogate endpoints, and device safety/benefit questions and to improve the design and conduct of clinical research. The person in this position will work closely with colleagues in the Pharmacoepidemiology group to define research questions, develop epidemiological protocols, and implement solutions.

The Sr. Director will provide thought leadership in Epidemiology and Post-marketing Surveillance, including deep knowledge of Healthcare Databases (Administrative Claims/EMR/Surveys/Registries etc) and associated Data mining/Analytical Methodology to utilize such data and advance internal research capabilities.

The role will involve leadership and/or participation in various task forces in addressing issues raised by product teams/regulatory agencies and will provide epidemiological and/or statistical consulting and support to product teams, and disseminate technical information through technical reports, presentation, and publication in peer-reviewed literature, as agreed by the team.

Additionally, the Sr. Director will support the Postmarket Surveillance Initiative (PSI) and further work to enhance safety and surveillance activities as part of product lifecycle management and play a key role in defining core processes, organizational strategy and leading implementation. The Sr. Director will also establish a robust signal assessment analytic capability in safety and surveillance of MD&D products - share best practices across other segments of the Enterprise (i.e. Pharma and Consumer); liaise with the Pharmaceutical Epidemiology group to establish close ties, leverage methods and approaches for enhanced signal assessment, and share best practices with Global Medical Safety group in Pharma; shape the external environment (e.g. engagement with Advamed, Professional Societies and health authorities) and advance MD&D capabilities in research methodology in collaboration with Regulators; enable innovation and growth by participating in the Independent Review process when epidemiologic expertise is needed; and deliver scientific input on FDA guidance documents as appropriate.

The Sr. Director will be expected to keep up-to-date with the FDA/Regulatory Agencies regarding applications of electronic, patient-level databases and other emerging epidemiologic research tools. A program of work exploring and developing new methodologies will be encouraged as will participation in external regulator-led, public-private and industry association for a with the aim of enhancing medical device safety capabilities. Work will also include, both within and outside of existing electronic databases, researching natural history of diseases to understand the inherent risks associated with the indications for devices; statistical risk assessment; using historical clinical trial data and other databases to develop an understanding of potential safety issues for new devices and new indications, based on experience with related compounds and devices; and planning and conducting meta-analyses of safety data from ongoing trials.

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Qualifications


An advanced degree in Epidemiology or related field is required, with a PhD or MD with training and degree in Epidemiology or related field highly preferred. Experience with suitable training in Epidemiology (e.g., an MPH, Biostatistics degree) or a related discipline preferred.

A minimum of 10 years of Epidemiology research experience is also required. Healthcare industry experience is required, with Pharmaceutical or Medical Device and Diagnostics industry experience highly preferred. A sophisticated understanding and the ability to interpret quantitative methods are required. Experience with writing statistical methods sections of study proposals and/or proposal requests or background epidemiologic material on specific diseases, conditions, or therapies is also required.

The incumbent should be viewed as a thought leader in the area of Outcomes Research and Post-market Safety Surveillance and be an active presenter at major conferences and forums in these areas.

Experience working with large administrative or medical records databases is required. Other preferred skills include: experience working with health authorities, Phase III/IV experience, and global experience. Experience in cross-functional partnering and leading people/teams in a matrix environment is required and essential for success.

Global and domestic travel of up to 30% may be required for this position.

BE VITAL in your career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-New Brunswick
Organization: Johnson & Johnson (6067)