Janssen Research & Development, LLC., a Johnson and Johnson Company is hiring an Director, to be located in Titusville or Raritan, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visithttp://www.janssenrnd.com/
for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Director will work largely independently, and may also function under the supervision of more senior members of the department, primarily providing support to the Metabolism franchise. The primary responsibilities of the Director will be to:
- Identify research study needs, draft proposals and protocols, and contribute to epidemiology strategy and study conduct across the clinical development program
- Literature reviews and synthesis, assistance of clinical teams with study design, and identification and evaluation of data resources to meet therapeutic needs
- Work closely with colleagues in the Epidemiology group when defining research questions, developing epidemiological protocols, and implementing solutions
- Participation in various teams in addressing issues raised by product teams/regulatory agencies
- 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
- 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 databases to develop an understanding of potential safety issues for new medications, and indications, based on experience with related compounds.
- Be involved in supporting efforts for the Disease Interception 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
- 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 6 years of hands-on experience is required
- At least 5 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 study proposals and/or proposal requests is required
- Experience working with large administrative or medical records databases is preferred
- At least 5 years Pharmaceutical industry experience is preferred
- Background in epidemiologic material on specific diseases, conditions, or therapies particularly relating to diabetes is preferred
- Experience working with health authorities is preferred
- Phase III/IV experience is preferred
- Experience working in a global environment is preferred
United States-New Jersey-TitusvilleOther Locations
North America-United States-New Jersey-RaritanOrganization
Janssen Pharmaceuticals, Inc (6062)Job Function