Senior Scientist, Global Clinical Pharmacology
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting a Senior Scientist, Global Clinical Pharmacology to be located in Raritan, NJ or 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.
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Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer
The position is responsible for the co-development and execution of Pharmacometrics (pharmacokinetic [PK] and pharmacodynamic [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.
The position is responsible for conducting hands-on modeling activities. 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. This Senior Scientist, Global Clinical Pharmacology role would include:
- Perform population PK/ PKPD analyses and report writing in support of regulatory submissions
- Support of projects in all stages of drug development using mechanism-based modelling & simulation methodologies (systems biology, disease progression modelling, landscape analysis, etc..) using data acquired at various development stages or using literate searched data
- Assist the ClinPharm Leader in the overall ClinPharm development strategy, the design of specific ClinPharm studies including the design of modelling and simulation-based assessments within clinical Phase 2/3 studies
- Develop and review of ClinPharm Population PK study design sections in clinical trial protocols and assist ClinPharm Leader in the defence of the synopsis and protocols at Synopsis Review Committee (SRC) and Protocol Review Committee (PRC) meetings
- Collaborate, 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
- Work in close collaboration with the Biostatistics and Programming group
- Develop/author/review (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
- Support installation and validation of new and existing software used by Pharmacometrics
- Train new hires and in-house contractors on PHARMACOMETRICS - related processes
- Carry out functional responsibilities in accordance with applicable SOPs and Regulatory requirements
- Assist in process improvement initiatives and SOP development
- PhD in Pharmacology, Pharmaceutical Sciences, Biochemistry, Biology, or equivalent with a track record of sound scientific achievement is required
- The successful candidate will have a minimum of 3 years of pharmaceutical research and development experience in the various aspects of Pharmacometrics , Modeling, and Simulation is required
- Excellent hands-on knowledge of data handling packages (SPLUS / R / SAS) is required
- Excellent data-handling skills and working knowledge of database structures is required
- Excellent hands-on knowledge of PK & PD Nonlinear Mixed effect modeling software packages is required
- A fundamental understanding of clinical drug development is required
- A fundamental understanding of ICH and other relevant regulatory guidelines and regulations is preferred
- Has begun to establish a level of expertise or scientific reputation though publications and presentations at external meetings is preferred
United States-New Jersey-Raritan
North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
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