Descrizione
The Epidemiology Asia Pacific is a function team within the Global Epidemiology Organization in Johnson & Johnson, providing scientific expertise to all pharmaceutical therapeutic areas specifically for APAC region by generating and disseminating Real-World Evidence from Real-World Data in APAC. The Epi APAC team consists of around 15 talents with expertise in Epidemiology, Biostatistics, Bioinformatics, and Data Science, who are based in Japan, China, Taiwan, and US. The goals of the Epi APAC team are to build up APAC focused infrastructure of RWD, apply scientific and innovative methodology, deliver high quality RWE to support life cycle drug development, evaluate the benefit and risk in post-approval clinical practice, and shape the regulatory environment cross APAC countries.
Key Responsibilities:
In this position, the Associate Director will play important leading role in the cross-functional collaborations in Taiwan and APAC region under the supervision of senior leaders of the Epi APAC. The key responsibilities include:
- To identify research study needs and solutions, independently draft study concepts 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 Taiwan and APAC region; to explore and assess data sources to evaluate disease natural history, treatment patterns, and medication safety / benefit questions.
- To collaborate with various functional teams, especially the R&D functions and safety team, across therapeutic areas; participate in various workforces in addressing research questions raised by product teams / regulatory agencies.
- To keep up to date with Regulatory Agencies regarding regulatory requirements for Post Authorization Studies and Risk Evaluation and Mitigation Strategies plans.
- To provide epidemiological and/or statistical consulting and education; disseminate clinical meaningful information through research reports, presentations, and publications in peer-reviewed journals as agreed by the team.
Qualifications:
- PhD in Epidemiology or a closely related field, OR MD with training and degree in Epidemiology or a closely related field, AND at least 5 years of pratical research experience; OR Master’s degree in Epidemiology AND at least 8 years of hands-on Epidemiology research experience, is required.
- Understanding of and the ability to interpret pharmacoepidemiology/quantitative methods is required.
- Experience with writing protocols in general and particularly the methods sections is required.
- Experience working with large administrative or medical records databases is required.
- Background in epidemiologic material on specific diseases, conditions, or therapies particularly relating to oncology and immunology is preferred.
- Experience working with health authorities is preferred.
- Strong verbal and written communication skills is required.
- Strong stakeholder management and experience effectively working in a complex, matrix environment is required.
Qualifiche
Please see above