Manager, Translational Science and Medicine
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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 Manager, Immunology Translational Science and Medicine 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 focus of this Manager/Study Responsible Scientist (SRS) position within Immunology Translational Science and Medicine (TSM) is to serve as a “bridge” between the preclinical Discovery Research and Biomarkers groups to Clinical Research for New Molecular Entities (NMEs). The Manager/SRS is a key member of early development clinical trial teams and leads the team designing clinical studies outlined in the early development plan (EDP). This work is at its core a deep collaboration between Disease Area experts, Translational Science (Biomarker) experts, Immunologic Pathway experts and many other essential development functions. The SRS works with Global Clinical Development Operations (GCDO) and the entire Trial Team to efficiently and effectively operationalize the studies. In addition, this role is also expected to contribute to the scientific evaluation of new disease pathways and targets, helping determine the best disease indications for the project.
TSM is an integrated group of scientists that includes a biomarkers group, and a clinical group which conducts early clinical development and experimental medicine studies. Janssen Immunology has a history of bringing life-changing therapies to patients with immune-mediated diseases. The TSM group will provide the key learnings/insights on the next wave of novel therapies for these patients. We are looking for someone with a BS, MS, PharmD, PhD or research nursing (RN) background, industry experience, and ideally a scientific background in Immunology, to join this collaborative research group, and help us bring these new therapies to patients.
• Collaborating with other team members in TSM, take a leadership role in the design, conduct, and analysis of TSM studies.
• Collaborate with Discovery Research, Translational Science, Clinical Pharmacology and Pharmacometrics, Global Clinical Operations (GCDO), and others to implement biomarker and translational research plans for early development programs.
• In collaboration with Immunologic Pathway experts and Program leads, evaluate the scientific literature on proposed disease targets and pathways, to determine the diseases most likely to respond to the new therapy.
• Supports the GCDO group with trial set up, conduct, and monitoring, and database locks.
• Ensure each study conduct adheres to Good Clinical Practices, International Conference of Harmony (ICH) guidelines, and standard operating procedures.
• In collaboration with GCDO, identifying clinical sites and CROs that will participate in ED trials.
• Interact with staff responsible for the design, set-up, execution, analysis and reporting of these studies.
• Review incoming data from the study for accuracy and completeness.
• Participate in the review and interpretation of clinical trial data to enable timely internal decision-making and external communication with investigators and regulatory agencies.
• Participate in the preparation and assure the accuracy of the clinical study report and any external publications.
• Report the status of clinical trials to management.
• BS, MS, PharmD, PhD or RN and 6-8 years industry experience.
• Experience with Ph 0, 1 and 2a studies in immunology indications is preferred.
• Experience with innovative trial designs (adaptive, platform, bucket) preferred.
• Previous clinical development experience is required.
• Ability to survey and interpret the scientific literature related to the assigned projects is required.
• Strong organizational skills and the ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business.
• Excellent written and verbal English communication skills are required.
• The ability to work in a matrix organization with cross-functional teams is required.
• The ability to travel up to 10%, including international travel is required.
• Proficient with Microsoft Office applications Excel, Powerpoint, and Word.
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.
United States-Pennsylvania-Spring House-
North America-United States-California-La Jolla
Janssen Research & Development, LLC (6084)
Clinical Research non-MD