Pharmacometrics Senior Scientist

Janssen Research & Development, L.L.C., a Johnson & Johnson company, is looking for a Senior Scientist, Pharmacometrics to be located in Spring House PA, Chesterbrook PA, La Jolla CA, San Francisco CA, Brisbane CA, Titusville NJ or Raritan NJ. Remote work options in the United States may be considered on a case-by-case basis and if approved by the Company.

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.

Objective of Position

The Senior Scientist, Pharmacometrics is 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.

The position is 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.

Senior Scientist, Pharmacometrics Main Accountabilities

• The key tasks can be formulated into 3 main pillars:
• 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 defence 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