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Director, Immunology Early Development
Johnson & Johnson
Spring House, PA, United States
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Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Director, Immunology Early Development (Clinical) to be located at the 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 immunology, oncology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
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, Immunology Early Development (ED) will be primarily responsible for designing and executing scientifically rigorous and informative first-in-human (FIH) and proof-of-concept (POC) studies within the Immunology Therapeutic Area. This position will play a ‘dual role’, contributing both scientific as well as clinical development expertise to ED projects. This work will include support for primarily Phase 0-2 studies.
Immunology ED is an integrated group of scientists that includes a world-class biomarker group and a highly experienced clinical group which conducts early clinical development and experimental medicine studies. ED is part of the larger Development group, which also includes Late Clinical Development. This close association of Early and Late Development provides unique learning and career development opportunities for our staff.
Janssen Immunology has a history of bringing life-changing therapies to patients with immune-mediated diseases. The ED group provides key learnings and insights on the next wave of novel therapies for patients with immune-mediated diseases. We are looking for a Physician with a strong immunology background (MD PhD, or research oriented MD), preferably with training and or experience in Rheumatology, to join this collaborative research group, and help us bring these new therapies to patients.
Responsibilities include:
• Lead a cross-functional team to design Early Clinical Development Plans and identify appropriate FIH, proof-of-mechanism (POM) and POC study designs for new molecular entity (NME) early development programs.
• Based upon the level of previous industry experience, may be a core member of the Rheumatology Disease Area Stronghold (DAS), the group that defines the short and long-term development strategy for new rheumatologic drugs at Janssen.
• Implement approved strategies for early development of NME's including FIH/POM/POC studies and for new indication assessment of compounds in development.
• Have ultimate responsibility for the medical management and safety aspects of the design, conduct and analysis of clinical trials for which he/she is responsible.
• Be an ED ambassador within and outside of the Immunology Therapeutic Area.
Qualifications for the Director include:
• An MD PhD, or an MD with a basic science research background is required.
• Previous clinical research experience with a minimum of 5 years industry experience is preferred. Clinical trials experience as an Investigator in an academic setting may be considered.
• Training or significant clinical trial experience in Rheumatology; experience in a relevant immunology/inflammation disease area such as GI/Inflammatory Bowel Disease, or Clinical Immunology may be considered.
• Strong Immunology scientific expertise is required.
• A record of peer reviewed publication and experience in scientific presentations is preferred.
• The ability to work in a matrix organization with cross-functional teams is required.
• Proven ability to lead and influence functional teams is required.
• The ability to travel up to 10%, including international travel is required.