Janssen Research & Development, LLC., a Johnson and Johnson Company is hiring an Associate Director, to be located in Titusville, 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 Associate Director will work under the supervision of more senior members of the department. The primary responsibilities of the Associate Director will be to identify research study needs, draft proposals and protocols, review study protocols and statistical analysis plans, and provide suggestions to improve them, and contribute to epidemiology strategy and study conduct across multiple therapeutic areas, however, the principal focus of this role is assessing risks associated with opioids. Secondary responsibilities may include literature reviews and evidence synthesis, assisting clinical teams with study design, and identification and evaluation of data resources to meet study needs. The Associate Director will work closely with colleagues in the Epidemiology group when defining research questions, developing epidemiological protocols, and implementing solutions.
Additional responsibilities may include but are not limited to the following:
- Participate in various teams in addressing issues raised by product teams/regulatory agencies
- Provide epidemiological and/or statistical consulting and support to product teams and to the different consortia that Janssen is part of, and disseminate technical information through technical reports, presentation, and publication in peer-reviewed literature as agreed by the teams
- Keep up to date with the FDA and other Regulatory Agencies regarding regulatory requirements for Post Approval Authorization Studies and Risk Evaluation and Mitigation Strategies plans
- PhD in epidemiology OR an MD with training and degree in Epidemiology is required
- At least 3 years of Epidemiology research experience is required
- Understanding and the ability to interpret quantitative methods is required
- Experience with writing protocols in general and particularly the statistical methods sections of study proposals for observational studies and/or proposal requests is required
- Experience working with large administrative or medical records databases is required
- This position will require someone who can work on multiple projects and with multiple people/teams concurrently
- Pharmaceutical or Medical Device and Diagnostics industry experience is preferred
- Background / experience in mental health/substance abuse research is preferred
- Experience working with health authorities is preferred
- Phase III/IV experience is preferred
United States-New Jersey-TitusvilleOrganization
Janssen Research & Development, LLC. (6084)Job Function