J&J Family of Companies Associate Director, Epidemiology in Beerse, Belgium
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.
We are currently hiring an Associate Director of Epidemiology within our Infectious Diseases & Vaccines TA.
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 visit http://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.
The Primary Responsibilities Of The Associate Director Will Be:
The Associate Director will work largely independently, and may also function under the supervision of more senior members of the department, primarily providing support to the ID/Vaccines/Global Public Health therapy areas.
Identify research study needs, draft proposals and protocols, and contribute to epidemiology (RWE) strategy and study conduct across the clinical development program
Work closely with colleagues in the Epidemiology group when defining research questions, developing epidemiological protocols, and implementing solutions
Directly (or indirectly through matrix leadership) supervise epidemiologist(s) supporting research needs relevant to the therapy areas, including setting of priorities, resource management, scientific review process, and development activities
Participation in various teams to design and deliver evidence which addresses issues raised by product teams/regulatory agencies across the life cycle where RWE can reduce uncertainty in decision-making.
Provide epidemiological and/or statistical consulting and support to product teams, and disseminate technical information through technical reports, presentations, and publications 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; observational research methods development; 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 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
A 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 of pharmaceutical industry experience is preferred
Experienced with non-randomized designs is strongly preferred.
Background in epidemiologic material on specific diseases, conditions, or therapies particularly relating to infectious disease or vaccines is preferred
Experience working with health authorities is preferred
Phase III/IV experience is preferred
Experience working in a global environment is preferred
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.
Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)