Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Director, Immunology Translational Science and Medicine to be located in Spring House, PA or Leiden, Netherlands.
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.
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The primary focus of this Director position within Immunology Translational Science and Medicine (TSM) is to serve as a “bridge” between the preclinical Discovery Research and Translational Science and Medicine (TSM) groups into Clinical Development for New Molecular Entities (NMEs). The Director leads a group of Clinical Scientists, and for selected studies, functions in the role of a Study Responsible Scientist (SRS) on early development 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 CS works with Global Clinical Development Operations (GCDO) and the entire Trial Team to efficiently and effectively operationalize the studies. In close collaboration with Strategy Program Leads, the Director will drive design, conduct, and analysis of Experimental Medicine and interventional Translational studies.
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.
Additional responsibilities are as follows:
- Collaborate with Discovery Research, Translational Science and Medicine, Clinical Pharmacology and Pharmacometrics, Global Clinical Operations (GCDO), and others to implement biomarker and translational research plans for early development programs.
- Drives the implementation of innovative trial designs including adaptive, platform and basket trials
- May lead the EDT (Early Development Teams) that creates the development strategy for NMEs.
- Represent TSM Trial Team at project functional stage-gate reviews.
- Participate in cross-functional trial teams.
- Help identify and collaborate with consultants, investigators, and key opinion leaders to optimize the preparation of early development strategies.
- Participate in the presentation of results and updates of projects at department, project, corporate and scientific meetings.
- Participate in process improvement efforts (TSM initiatives, Immunology TA initiatives and cross-Pharma initiatives, as applicable).
- BS, MS, PharmD, PhD or RN with 10+ years industry experience is required.
- Clinical Development experience is required.
- Experience with Ph 0, 1 and 2a studies in immunology indications is preferred.
- Experience with innovative trial designs (adaptive, platform, bucket) is preferred.
- Ability to survey and interpret the scientific literature related to the assigned projects is required.
- Working knowledge of the use of Microsoft suite of software products including Excel and Word is required. Ability to do more complex data analysis with Excel or similar programs is preferred.
- Good organizational skills with the ability to multi-task and prioritize assignments is required.
- Being able to work in a (virtual) cross-functional team environment is required.
- Willingness and ability to travel, including trans-Atlantic travel (up to ~10%) is required.