Senior Scientist, Pharmacometrics at Johnson & Johnson in Spring House, PA
Job Description Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Scientist, Pharmacometrics, 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. The Senior Scientist, Pharmacometrics position will be responsible for conducting mechanism-based Pharmacokinetic/Pharmacodynamic (PK/PD) and Quantitative Systems Pharmacology (QSP) modeling, with the aim to guide effective translation and development of clinical programs. Additional responsibilities may include pharmacometrics modeling and simulation activities for ClinPharm-sponsored and supported studies for products in any phase of clinical development; the generation and review of clinical pharmacology and pharmacometrics documents related to regulatory submissions; preparing responses to Agency questions; and preparing for and/or attending meetings with Regulatory Agencies and Advisory Committee Meetings. Key
Responsibilities:
Support high impact product development projects in all stages of drug development using mechanism and physiologically-based PK/PD modeling and simulation methodologies, including QSP modelling, physiological based pharmacokinetic (PBPK) modeling, disease progression modelling and model-based landscape analysis, etc. Demonstrate high proficiency in the development and application of models to address drug-discovery and development questions. Perform exploratory modelling projects with quick turnaround to support critical business decisions. Provide leadership to and collaboration with multidisciplinary project teams to develop and apply QSP models. Supervise and actively participate in the review and monitoring of outsourced modeling activities conducted at Contract Research Organizations (CROs). Guide and supervise junior scientists in the group. Serve as a point-of-contact person on QSP project teams, work in close collaboration with key Therapeutic Area (TA) stakeholders, clinical teams and related functional groups to maximize the value of mechanistic and QSP modeling. Provide scientific and strategic expertise across TAs (Immunology, Oncology, Cardiovascular and Metabolism, Neuroscience, Infectious Diseases and Vaccine) and promote model-informed drug discovery and development strategies. Qualifications A minimum of a Ph.D. degree in Pharmaceutical Sciences, Systems Biology, Pharmacology, Mathematics, Engineering, or a related disciplines related. A minimum of 2 years of experience in using a quantitative approach in describing biological systems and applying quantitative tools to enable rational and efficient drug development is required. Strong understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation, including numerical methods, parameter estimation/optimization, and ordinary differential equations (ODEs), and how these can be applied in the development of complex models of biological pathways and systems is required. Proficiency in advanced PKPD modeling and simulation software (e.g. Matlab/Simbiology, Julia, Python, NONMEM, Monolix, etc.) is required. Experience in building, validating and using QSP models or deterministic models of biological pathways/systems to support basic science and/or translational clinical research is strongly preferred. Good understanding of the basic principles of Pharmacokinetics and Pharmacodynamics for conventional large and small molecule therapeutics as well novel therapeutic modalities is preferred. Experience with general programming and data analysis tools/languages (e.g. R, SpotFire, SQL) is preferred. Strong record of publications preferred. Must have excellent oral and written communication skills. Must be a self-motivated team player who excels in a collaborative, multi-disciplinary team environment. The ability to interact and collaborate effectively with scientists in other disciplines is required.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Support high impact product development projects in all stages of drug development using mechanism and physiologically-based PK/PD modeling and simulation methodologies, including QSP modelling, physiological based pharmacokinetic (PBPK) modeling, disease progression modelling and model-based landscape analysis, etc. Demonstrate high proficiency in the development and application of models to address drug-discovery and development questions. Perform exploratory modelling projects with quick turnaround to support critical business decisions. Provide leadership to and collaboration with multidisciplinary project teams to develop and apply QSP models. Supervise and actively participate in the review and monitoring of outsourced modeling activities conducted at Contract Research Organizations (CROs). Guide and supervise junior scientists in the group. Serve as a point-of-contact person on QSP project teams, work in close collaboration with key Therapeutic Area (TA) stakeholders, clinical teams and related functional groups to maximize the value of mechanistic and QSP modeling. Provide scientific and strategic expertise across TAs (Immunology, Oncology, Cardiovascular and Metabolism, Neuroscience, Infectious Diseases and Vaccine) and promote model-informed drug discovery and development strategies. Qualifications A minimum of a Ph.D. degree in Pharmaceutical Sciences, Systems Biology, Pharmacology, Mathematics, Engineering, or a related disciplines related. A minimum of 2 years of experience in using a quantitative approach in describing biological systems and applying quantitative tools to enable rational and efficient drug development is required. Strong understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation, including numerical methods, parameter estimation/optimization, and ordinary differential equations (ODEs), and how these can be applied in the development of complex models of biological pathways and systems is required. Proficiency in advanced PKPD modeling and simulation software (e.g. Matlab/Simbiology, Julia, Python, NONMEM, Monolix, etc.) is required. Experience in building, validating and using QSP models or deterministic models of biological pathways/systems to support basic science and/or translational clinical research is strongly preferred. Good understanding of the basic principles of Pharmacokinetics and Pharmacodynamics for conventional large and small molecule therapeutics as well novel therapeutic modalities is preferred. Experience with general programming and data analysis tools/languages (e.g. R, SpotFire, SQL) is preferred. Strong record of publications preferred. Must have excellent oral and written communication skills. Must be a self-motivated team player who excels in a collaborative, multi-disciplinary team environment. The ability to interact and collaborate effectively with scientists in other disciplines is required.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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