Johnson & Johnson Careers
Requisition ID: 1867190412
The Manager of Epidemiology will have the opportunity to work independently, and in this role will also function under the supervision of more senior members of the department, primarily providing support to the Oncology franchise.
The primary responsibilities of the Manager will be to:
- Assist with identifying research study needs, drafting proposals and protocols, and contributing to epidemiology strategy and study conduct across the clinical development program
- Conduct literature reviews and synthesis; provide assistance to clinical teams with study design; and identify and evaluate data resources to meet therapeutic needs
- Work closely with colleagues in the Epidemiology Analytics group when defining research questions, developing epidemiological protocols, and implementing solutions
- Provide epidemiological and/or statistical consulting, education and support to product teams, and disseminate technical information through technical reports, presentation, and publication in peer-reviewed literature, as agreed by the team
- 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 indication; statistical risk assessment; using historical clinical trial data and other observational databases to develop an understanding of potential safety issues for new medications, and indications, based on experience with related compounds.
- Assist with efforts supporting the World Without Disease Accelerator, the Office of the Chief Medical Officer, and cross-sector collaborations as prioritized
- Keep up to date with the FDA and other Regulatory Agencies regarding regulatory requirements for Post Approval Authorization Studies and Risk Management plans and the development of formal guidance for use of RWE for Regulatory Decision Making.
- PhD in epidemiology or a closely related field OR MD with training and degree in Epidemiology or a closely related field OR Master’s degree with at least 2 years of hands-on experience is required
- At least 2 years of Epidemiology research experience is required
- Must have an understanding and the ability to interpret quantitative methods
- Experience with writing protocols in general and particularly the statistical methods sections of observational study proposals and/or proposal requests is required
- Experience working with large administrative or medical records databases is preferred
- At least 2 years of applied pharmacoepidemiology research is preferred
- Background in epidemiologic material on specific diseases, conditions, or therapies particularly relating to oncology or immunology is preferred
- Experience working with health authorities is preferred
- Phase III/IV medicine development experience is preferred
- Experience working in a global environment is preferred
- A track record of authoring scientific communications (peer-reviewed publications, poster or oral presentations at conferences, technical reports) is required; author position commensurate with prior academic training and working environments.
United States-New Jersey-Raritan-
Janssen Research & Development, LLC. (6084)