J&J Family of Companies
Senior Principal Scientist, Clinical Pharmacology and Pharmacometrics
J&J Family of Companies, Juneau, Alaska, us, 99812
J&J Family of Companies - Senior Principal Scientist, Clinical Pharmacology and Pharmacometrics
Location: Juneau, AlaskaDescriptionJohnson & Johnson Innovative Medicine is recruiting for a Senior Principal Scientist, Clinical Pharmacology and Pharmacometrics, located in Spring House, PA or Raritan, NJ. Remote work options within the US may be considered on a case-by-case basis.The Therapeutic Area (TA) Clinical Pharmacology (CP) Senior Principal Scientist 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.Key Responsibilities:Developing and executing CP development strategy in supporting the selection of the right dose-regimen, in the right population, using the relevant biomarkers and the right endpoint to achieve differentiation and develop a CP package that enables global product registration.Accountable for all CP trial design, analysis of data, reporting and interpretation of results.Design and execution of appropriate modeling plans along with the Pharmacometric scientist assigned to the project.Conducting hands-on pharmacokinetic and pharmacokinetic-pharmacynamic analysis for drug development projects.Contribute to the required components of regulatory submissions and be responsible for responding to regulatory authority queries.Provide mentorship to CP colleagues on hands-on aspects of clinical pharmacology.Drive early alignment on key development questions where CP principles could be applied.Attend governance meetings, as necessary, ensure that CP plans are flawlessly executed, on time for efficient decision making.Lead the integration of input from all relevant functions as well as the preferred sourcing partners to formulate an efficient execution plan.Ensure access to optimum capabilities including resourcing for CP studies, developing sustainable strategy to acquire or develop internally all necessary CP techniques that are aligned with the disease area of interest to Janssen R&D.QualificationsEducation:PhD (or equivalent experience) in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 6 years of experience in pharmaceutical or related field (or relevant experience).Experience and Skills:Required:Advanced understanding of PK, PD, PK/PD, and/or Translational Medicine.Understanding of advanced analysis methods (e.g., population analysis, PBPK, QSP) and modeling tools (e.g., NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab).Demonstrated understanding of overall process of drug development including model informed drug development (MIDD) and the overall pharmaceutical R&D process.Drug development experience in the therapeutic area of interest including understanding of disease, patient population, and treatment paradigm.Working knowledge of US, European, and Asian regulatory requirements and guidelines.Good oral and written communication skills, including ability to interpret PK and PKPD results and prepare presentations to communicate findings effectively.Has established a strong level of expertise and scientific reputation through multiple publications and presentations.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Primary Location:
NA-US-Pennsylvania-Spring HouseOther Locations:
NA-United States, NA-US-New Jersey-RaritanJob Function:
Pharmacokinetics & Pharmacometrics
#J-18808-Ljbffr
Location: Juneau, AlaskaDescriptionJohnson & Johnson Innovative Medicine is recruiting for a Senior Principal Scientist, Clinical Pharmacology and Pharmacometrics, located in Spring House, PA or Raritan, NJ. Remote work options within the US may be considered on a case-by-case basis.The Therapeutic Area (TA) Clinical Pharmacology (CP) Senior Principal Scientist 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.Key Responsibilities:Developing and executing CP development strategy in supporting the selection of the right dose-regimen, in the right population, using the relevant biomarkers and the right endpoint to achieve differentiation and develop a CP package that enables global product registration.Accountable for all CP trial design, analysis of data, reporting and interpretation of results.Design and execution of appropriate modeling plans along with the Pharmacometric scientist assigned to the project.Conducting hands-on pharmacokinetic and pharmacokinetic-pharmacynamic analysis for drug development projects.Contribute to the required components of regulatory submissions and be responsible for responding to regulatory authority queries.Provide mentorship to CP colleagues on hands-on aspects of clinical pharmacology.Drive early alignment on key development questions where CP principles could be applied.Attend governance meetings, as necessary, ensure that CP plans are flawlessly executed, on time for efficient decision making.Lead the integration of input from all relevant functions as well as the preferred sourcing partners to formulate an efficient execution plan.Ensure access to optimum capabilities including resourcing for CP studies, developing sustainable strategy to acquire or develop internally all necessary CP techniques that are aligned with the disease area of interest to Janssen R&D.QualificationsEducation:PhD (or equivalent experience) in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 6 years of experience in pharmaceutical or related field (or relevant experience).Experience and Skills:Required:Advanced understanding of PK, PD, PK/PD, and/or Translational Medicine.Understanding of advanced analysis methods (e.g., population analysis, PBPK, QSP) and modeling tools (e.g., NONMEM, R, Gastroplus, Simcyp, Winnonlin, Matlab).Demonstrated understanding of overall process of drug development including model informed drug development (MIDD) and the overall pharmaceutical R&D process.Drug development experience in the therapeutic area of interest including understanding of disease, patient population, and treatment paradigm.Working knowledge of US, European, and Asian regulatory requirements and guidelines.Good oral and written communication skills, including ability to interpret PK and PKPD results and prepare presentations to communicate findings effectively.Has established a strong level of expertise and scientific reputation through multiple publications and presentations.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Primary Location:
NA-US-Pennsylvania-Spring HouseOther Locations:
NA-United States, NA-US-New Jersey-RaritanJob Function:
Pharmacokinetics & Pharmacometrics
#J-18808-Ljbffr