Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Senior Director Global Epidemiology Cross TA to be located in Spring House, PA or 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 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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The primary role of this position is to oversee and manage the therapeutic area Epidemiology teams whose role is to design and implement strategies and studies to generate evidence from a number of sources including electronic, patient-level database(s), randomized trials, registries, surveys and other information sources to evaluate disease natural history, clinical and surrogate endpoints, and drug safety/benefit questions, and to improve the design and conduct of clinical research. Responsibilities also include synthesis of prior research; assisting clinical teams with study design, and identification and evaluation of potentially suitable databases;protocol preparation and, supervision of more junior colleagues when requested to do so by the head of the department. This role will work closely with colleagues in the other functions in the Epidemiology group (Benefit-Risk, Analytics) to align strategy and resources to assure that the TA Epidemiology function optimally fulfills its role to define research questions, develop epidemiological protocols, and implement solutions.
Secondary responsibilities may include:
Ultimate responsibility for the scientific integrity of studies, study execution, adherence to corporate policy, and management of team members, either directly or as part of a project matrix
Adherence and implementation of governance, established standards, and review processes
Participation in or oversight of various task forces that address issues raised by product teams/regulatory agencies, providing epidemiological and/or statistical consulting and support to product teams, Regulatory Affairs, Health Policy, and participating in or leading the production and dissemination of technical information through technical reports, making presentations to company and external groups, and publication in peer-reviewed literature as agreed by the team.
Responsibility to assure timely submission of ongoing regulatory required reports and documents including PSURs and Risk Management-related documents.
Close collaboration and alignment with the Global Safety organization, Regulatory Affairs, the Office of the Chief Medical Officer, and the R&D organization are critical for success.
Remaining up-to-date with the FDA and other Regulatory Agency positions and guidance regarding applications of electronic, patient-level databases and other emerging epidemiologic research tools, actively supports external policy initiatives in leadership roles including but not limited to professional organizations, industry-sponsored initiatives, public-private partnerships, and academic collaborations and it is expected that the Senior Director will support a program of work exploring and developing new methodologies, or substantive research to advance the underlying science of epidemiology.
Research including, both within and outside of existing electronic databases, exploring natural history of diseases to understand the inherent risks associated with the indications for medications; 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; and planning and conducting meta-analyses of safety data from ongoing trials.
Qualifications for the Senior Director include:
PhD in Epidemiology or a closely related field (e.g., Biostatistics, Outcomes Research, Health Economics, Health Services Research), or MD with training in Epidemiology or a closely related field
Minimum of 15 years of Epidemiology / Observational research experience
Experience as a direct or matrix manager of other scientists
Sophisticated understanding of, and the ability to interpret quantitative methods
Ten + years of pharmaceutical industry experience is required
Excellent communication skills are required
Recognized scientific experience and credibility are critical skills required for consideration as well as for success in the role.
Expertise in management of teams and collaboration with external investigators, developing and influencing strategy, and the proven ability to work in a dynamic environment of research.
The department has established itself as a vibrant and innovative community embedded in a corporate culture that is focused on ethical, CREDO driven behavior.
United States-New Jersey-Titusville
North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)