J&J Family of Companies
Senior Principal Scientist, Pharmacometrics Leader
J&J Family of Companies, Baton Rouge, Louisiana, us, 70873
J&J Family of Companies - Senior Principal Scientist, Pharmacometrics Leader
Location: Baton Rouge, LouisianaDescriptionJohnson and Johnson is currently seeking a
Senior Principal Scientist, Pharmacometrics Leader
located in Raritan, NJ or Spring House, PA. 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 and landscape to influence go/no go decisions.Plan, perform, and/or provide oversight for appropriate analyses of clinical translation, dose/exposure-response relationships.Responsible for planning, summarization and interpretation of results of PK and PK/PD analyses.Prepare CP contributions to regulatory documents including briefing books, submission packages, and responses to health authority questions.Stay abreast of model informed drug development, analysis methodology and overall drug development process.Apply relevant technical trainings/learnings to daily responsibilities, with focus on value/impact.Foster a 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 the same fields is preferred with 6 years of experience.Required:Advanced understanding of PK, PD, PK/PD, and/or Translational Medicine.Experience with modeling tools (e.g., NONMEM, R, Gastroplus).Understanding of advanced analysis methods (e.g., population analysis, PBPK).Good oral and written communication skills.Preferred:Drug development experience including understanding of disease, patient population, and treatment paradigm.The anticipated base pay range for this position in the US is $135,000 to $232,300. This position is eligible for an annual performance bonus and various employee benefit programs.Primary Location:
NA-US-New Jersey-RaritanOther Locations:
NA-United States, NA-US-Pennsylvania-Spring HouseJob Function:
Pharmacokinetics & Pharmacometrics
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Location: Baton Rouge, LouisianaDescriptionJohnson and Johnson is currently seeking a
Senior Principal Scientist, Pharmacometrics Leader
located in Raritan, NJ or Spring House, PA. 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 and landscape to influence go/no go decisions.Plan, perform, and/or provide oversight for appropriate analyses of clinical translation, dose/exposure-response relationships.Responsible for planning, summarization and interpretation of results of PK and PK/PD analyses.Prepare CP contributions to regulatory documents including briefing books, submission packages, and responses to health authority questions.Stay abreast of model informed drug development, analysis methodology and overall drug development process.Apply relevant technical trainings/learnings to daily responsibilities, with focus on value/impact.Foster a 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 the same fields is preferred with 6 years of experience.Required:Advanced understanding of PK, PD, PK/PD, and/or Translational Medicine.Experience with modeling tools (e.g., NONMEM, R, Gastroplus).Understanding of advanced analysis methods (e.g., population analysis, PBPK).Good oral and written communication skills.Preferred:Drug development experience including understanding of disease, patient population, and treatment paradigm.The anticipated base pay range for this position in the US is $135,000 to $232,300. This position is eligible for an annual performance bonus and various employee benefit programs.Primary Location:
NA-US-New Jersey-RaritanOther Locations:
NA-United States, NA-US-Pennsylvania-Spring HouseJob Function:
Pharmacokinetics & Pharmacometrics
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