Johnson & Johnson Careers
Senior Director, Immunology Epidemiology
Spring House, Pennsylvania
Requisition ID: 2067190108
Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Senior Director Immunology Epidemiology to be located in Spring House, PA.
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 be the key epidemiology leader for the Immunology franchise. Primary responsibilities will be to engage with Disease Area Stronghold (DAS) and Pathway Stronghold (PAS) teams in designing strategies for each DAS and PAS that optimally incorporate exploration of external patient-level data sources to evaluate and define disease natural history, clinical and surrogate endpoints, assess drug or device safety/benefit questions, and improve the design and conduct of clinical and discovery research. Responsibilities also include engaging directly or coordinating engagement through team members with project teams in Clinical R&D, safety and medical affairs to explore electronic, patient-level database(s) and other sources of data to evaluate issues related to safety and/or benefit/risk either during development or post launch. In addition, other responsibilities may include leading studies of disease natural history, clinical and surrogate endpoints, and to provide expert consultation which informs the design, conduct and evaluation of clinical research (e.g. reduce uncertainty in decision making, increase efficiency). Direct and matrix management of other scientists will be required.
Secondary responsibilities may include:
• Collaborating with clinical teams as an epidemiology expert to inform study design, identification and evaluation of potentially suitable real world data sources.
• Working closely with colleagues in the Epidemiology group to define research questions, develop epidemiologic protocols, interpret results and implement solutions needed to achieve the strategic goals of each DAS and/or PAS.
• Developing strategy and prioritization of research undertaken by the epidemiology function will rest with this position and the incumbent will be contributing to the evidence generation strategy more broadly for the Immunology franchise.
• Participation in various task forces that address issues raised by product teams/regulatory agencies and providing epidemiologic and/or statistical consulting and support to DAS and PAS Advisory Boards, 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.
• Requiring consistent on-site presence with Immunology and Epidemiology colleagues and expertise in the existing and emerging tools for insight generation and analyses including distributed database studies, patient preference/benefit risk decision making, and meta-analysis.
• Remaining up-to-date with the FDA/Regulatory Agencies’ positions and guidance regarding applications of electronic, patient-level databases and other emerging epidemiologic research tools to generate RWE of sufficient quality and relevance which meets the evidentiary standard for regulatory decision making.
• Supporting external policy initiatives in leadership roles including, professional organizations, industry-sponsored initiatives, public-private partnerships, and academic collaborations
• Leading or contributing to a program of work exploring and developing new methodologies, or substantive research to advance the underlying science of (pharmaco)epidemiology
Qualifications for the Senior Director include:
• PhD in Epidemiology or a closely related field or an MD with training in Epidemiology or closely related field is required
• Minimum of 10 years of Epidemiology research experience is required
• Five + years of pharmaceutical industry experience is required
• Experience as a direct or matrix Manager of other scientists and interest in developing people is required
• A sophisticated understanding of and the ability to interpret methods is required
• Strong oral and written communication skills are required
• Experience with study proposals and/or proposal requests or background epidemiologic material on biologics and immunological diseases, conditions or therapies is a strong asset
• Record of publication in peer-reviewed journals is a plus
• Experience conducting observational research utilizing large administrative databases, electronic medical records databases or cohorts/registries is required
• Experience working with health authorities and phase III/IV research programs are preferred; global experience is an asset
• Recognition nationally or internationally from peers outside of the company for expertise in the field is preferable
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC. (6084)