J&J Family of Companies
Senior Principal Scientist, Pharmacometrics Leader
J&J Family of Companies, Charleston, West Virginia, us, 25329
J&J Family of Companies - Senior Principal Scientist, Pharmacometrics Leader
Location: Charleston, West VirginiaDescriptionJohnson and Johnson is currently seeking a
Senior Principal Scientist, Pharmacometrics Leader . Remote work options may be considered on a case-by-case basis and if approved by the company.The Senior Principal Scientist, Pharmacometrics role within Clinical Pharmacology & Pharmacometrics (CPP) is to apply and promote clinical pharmacology expertise including the design of clinical pharmacology components of simple and complex clinical studies, pharmacokinetics (PK), pharmacodynamics (PD) analysis and reporting, and application of principles of model-informed drug development (MIDD) to programs in all stages of development, ranging from pre-New Molecular Entity (NME) declaration through post-marketing support.Primary Responsibilities:Devise model informed drug development strategy via application of quantitative methods to integrate knowledge of PK, PD (e.g., biomarker, efficacy, and/or safety), patient characteristics, disease states, competitive landscape to influence go/no go decisions, support patient sub-population, dose and dosage regimen selection, and optimize study designs throughout drug development.Plan, perform, and/or provide oversight for appropriate analyses (e.g. population and/or modeling and simulation analysis of PK and/or PD data) of clinical translation, dose/exposure-response relationships, to guide dose regimen and optimize study design.Responsible for planning, summarization and interpretation of results of PK and PK/PD analyses with respect to their impact on a development program and clinical use.Prepare CP contributions to regulatory documents including briefing books, submission packages, responses to health authority questions, and other regulatory documents.Participate in the evaluation of potential business development opportunities.Stay abreast of model informed drug development, analysis methodology and overall drug development process, including regulatory guidance, and methods in modelling and simulation.Apply relevant technical trainings/learnings to daily responsibilities, with focus on value/impact.Foster working environment that promotes collaboration, innovation, and creativity.QualificationsEducation:Master’s Degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 9 years of experience in pharmaceutical, biomedical, or related field required.PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 6 years of experience in pharmaceutical, biomedical, or related field preferred.Required:Advanced understanding of PK, PD, PK/PD, and/or Translational Medicine.Experience with modeling tools (e.g., NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab).Understanding of advanced analysis methods (e.g., population analysis, PBPK, QSP).Demonstrated understanding of overall process of drug development including model informed drug development (MIDD) and the overall pharmaceutical R&D process.Good oral and written communication skills, including ability to interpret PK and PKPD results and prepare presentations to communicate findings effectively and influence stakeholders.Up to 10% travel – Domestic & International.Preferred:Drug development experience including understanding of disease, patient population, and treatment paradigm.Demonstrated ability to apply innovative tools to enable rational and efficient clinical pharmacology strategy of the drug development plan.Compensation and Benefits:The anticipated base pay range for this position in the US is $135,000 to $232,300. Employees may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, and retirement plans.This job posting is anticipated to close on July 17, 2024. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
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Location: Charleston, West VirginiaDescriptionJohnson and Johnson is currently seeking a
Senior Principal Scientist, Pharmacometrics Leader . Remote work options may be considered on a case-by-case basis and if approved by the company.The Senior Principal Scientist, Pharmacometrics role within Clinical Pharmacology & Pharmacometrics (CPP) is to apply and promote clinical pharmacology expertise including the design of clinical pharmacology components of simple and complex clinical studies, pharmacokinetics (PK), pharmacodynamics (PD) analysis and reporting, and application of principles of model-informed drug development (MIDD) to programs in all stages of development, ranging from pre-New Molecular Entity (NME) declaration through post-marketing support.Primary Responsibilities:Devise model informed drug development strategy via application of quantitative methods to integrate knowledge of PK, PD (e.g., biomarker, efficacy, and/or safety), patient characteristics, disease states, competitive landscape to influence go/no go decisions, support patient sub-population, dose and dosage regimen selection, and optimize study designs throughout drug development.Plan, perform, and/or provide oversight for appropriate analyses (e.g. population and/or modeling and simulation analysis of PK and/or PD data) of clinical translation, dose/exposure-response relationships, to guide dose regimen and optimize study design.Responsible for planning, summarization and interpretation of results of PK and PK/PD analyses with respect to their impact on a development program and clinical use.Prepare CP contributions to regulatory documents including briefing books, submission packages, responses to health authority questions, and other regulatory documents.Participate in the evaluation of potential business development opportunities.Stay abreast of model informed drug development, analysis methodology and overall drug development process, including regulatory guidance, and methods in modelling and simulation.Apply relevant technical trainings/learnings to daily responsibilities, with focus on value/impact.Foster working environment that promotes collaboration, innovation, and creativity.QualificationsEducation:Master’s Degree in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 9 years of experience in pharmaceutical, biomedical, or related field required.PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 6 years of experience in pharmaceutical, biomedical, or related field preferred.Required:Advanced understanding of PK, PD, PK/PD, and/or Translational Medicine.Experience with modeling tools (e.g., NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab).Understanding of advanced analysis methods (e.g., population analysis, PBPK, QSP).Demonstrated understanding of overall process of drug development including model informed drug development (MIDD) and the overall pharmaceutical R&D process.Good oral and written communication skills, including ability to interpret PK and PKPD results and prepare presentations to communicate findings effectively and influence stakeholders.Up to 10% travel – Domestic & International.Preferred:Drug development experience including understanding of disease, patient population, and treatment paradigm.Demonstrated ability to apply innovative tools to enable rational and efficient clinical pharmacology strategy of the drug development plan.Compensation and Benefits:The anticipated base pay range for this position in the US is $135,000 to $232,300. Employees may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, and retirement plans.This job posting is anticipated to close on July 17, 2024. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
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