Senior Scientist, Pharmacometrics
- Titusville, NJ
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting a Senior Scientist, Pharmacometrics to be located in Spring House, PA with consideration given to Raritan, NJ and Titusville, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC. is part of the Janssen Pharmaceutical Companies.
You, the Senior Scientist, Pharmacometrics will be responsible for the co-development and execution PK/PD Modeling and Simulation activities related to the research, design, implementation, data analysis, interpretation, reporting, and publication of ClinPharm-sponsored and -supported studies for products in any phase of development. Additional responsibilities include the generation and review of clinical pharmacology documents related to regulatory submissions, preparing responses to Agency questions and preparing for and/or attending meetings with Regulatory Agencies and Advisory Committee Meetings.
You will be responsible for contributing to (all) or conducting advanced research (e.g., model-based population PK and PK/PD drug development). Individual advancement is based, in part, on the educational background, degree of experience, displaying a progression in the level of expertise and level of independence shown.
• Perform population PK/ PKPD analyses and report writing in support of regulatory submissions
• Support of Big Impact product development projects in all stages of drug development using mechanism-based modeling & simulation methodologies (systems biology, disease progression
• modelling, landscape analysis, etc..) using data acquired at various development stages or using literate searched data.
• Perform exploratory modelling projects asking quick turnaround to support critical business decisions
• Beyond and as a result of the above, support and input is given into:
• Development and review of ClinPharm Population PK study design sections in clinical trial protocols and assistance is provided to the ClinPharm Leader in the defense of the synopsis and protocols at Synopsis Review Committee (SRC) and Protocol Review Committee (PRC) meetings
• Assists the ClinPharm Leader in the overall ClinPharm development strategy, the design of specific ClinPharm studies including the design of modeling and simulation-based assessments within clinical Phase 2/3 studies
• Collaboration, when applicable, with the ClinPharm Leader and ClinPharm Program Manager in the evaluation of Contract Research Organization (CRO) capabilities. Actively participates in the review and monitoring of outsourced Population PK/PD-related activities
• Working in close collaboration with the Biostatistics and Programming group
• Writes population PK/ PKPD analysis plans
• Development/writing/reviewing (including QC) ClinPharm sections of various internal documents and presentations.
• Establish scientific credibility inside and outside the company (e.g., abstracts, posters, publication in peer reviewed journal, podium presentation at conferences)
• Initiate and contribute to the development of new scientific methodologies, while ensuring high quality standards
• Demonstrates in-depth knowledge/expertise in Clinical Pharmacology and/or associated disciplines by developing scientific projects and effectively applies state-of-the-art scientific knowledge to these projects
• A Ph.D. Degree in Pharmaceutics, Clinical Pharmacology, Biomedical Engineering or Statistics with a minimum of two (2) years of relevant experience (including postdoctoral studies) OR an M.S. Degree in Pharmaceutics, Clinical Pharmacology, Biomedical Engineering or Statistics, PharmD, or equivalent and a minimum of five (5) years of relevant experience.
• The ability to apply knowledge of clinical PK & PK/PD concepts is required.
• Experience utilizing Nonmem, R or other PK/PD modelling software is required.
• Experience in one or more therapeutic areas is required.
• Oncology and Immunology experience is preferred.
• Has begun to establish a level of expertise or scientific reputation though publications and presentations at external meetings is a plus.
• Strong written and verbal communication skills and the ability to present to groups is required.
• Must be a team player.
• This position is located in Spring House, PA with consideration given to Raritan, NJ and Titusville, NJ and may require up to 10% domestic and international travel.
United States-Pennsylvania-Spring House-
North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville
Janssen Research & Development, LLC (6084)
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