Janssen Research & Development, LLC., a Johnson and Johnson Company is recruiting for an Associate Director, Epidemiology, to be located in Tokyo, Japan.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at [...] and follow us @JanssenGlobal. Janssen Research & Development, LLC.is part of the Janssen Pharmaceutical Companies.
The Epidemiology Japan function is part of the Global Epidemiology department in Janssen to support cross-therapeutic areas by generating and disseminating real-world evidence about disease, treatment, health service utilization, and safety and effects of medical products from healthcare data analyses as well as prospective Epidemiology studies.
In this position, the Associate Director will lead and implement the Epidemiology strategy in Japan under the supervision of senior members of the Global Epidemiology department. The key responsibilities include:
Identify research study needs, implementing solutions, draft proposals and protocols, review study protocols and statistical analysis plans, and contribute to study conduct across multiple therapeutic areas.
To identify and evaluate existing external electronic patient-level databases, and ongoing population-based studies relevant to therapeutic areas of interest in Japan; to determine the extent, linkage, and quality of the databases for observational research; to explore and analyze data sources to evaluate disease natural history, treatment patterns, and medication safety/benefit questions, and to improve the design and conduct of clinical research
Keep up to date with Regulatory Agencies in Japan regarding regulatory requirements for Post Authorization Studies and Risk Evaluation and Mitigation Strategies plans in Japan.
Collaborate with various functional teams, especially the safety team in Japan, across therapeutic areas; participate in various workforces in addressing research questions raised by product teams/regulatory agencies
Align global and local Epidemiology strategies and to enhance communication and networking within the department and within the company.
Ph.D. in Epidemiology OR M.D. with training and degree in Epidemiology or a closely related field is required
Experience and Skills:
Minimum 3 year of hands-on experience in Epidemiology, outcomes research or related discipline
Excellent interpersonal and communication skills with multiple functional teams
Experience with writing protocols in general, understanding and the ability to interpret quantitative methods, and results interpretations of observational studies
Experience working with large administrative or medical records databases
Excellent communication skills in English & Japanese is required
Pharmaceutical or Medical Device and Diagnostics industry experience
Experience working with health authorities
Phase III/IV experience
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location Japan-Tokyo-To-Chiyoda-
Organization Janssen Pharmaceutical K.K. (7195)
Job Function R&D
Requisition ID 2105897890W