J&J Family of Companies
Senior Principal Scientist, Pharmacometrics Leader
J&J Family of Companies, Concord, New Hampshire, United States, 03306
J&J Family of Companies - Senior Principal Scientist, Pharmacometrics Leader
Johnson 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.DescriptionThe 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. The Senior Principal Scientist CPP Leader is responsible and accountable for developing compound specific Clinical Pharmacology strategy for the development of a compound, including interactions with regulatory agencies and functions as CPP Leader on the Compound Development Teams (CDT) working in collaboration with various stakeholders within the team and within Quantitative Sciences (e.g., Statistics, Pharmacometrics). The Senior Principal Scientist CPP Leader can independently execute the day-to-day operations for the clinical pharmacology aspects of the assigned programs and may provide management directly or indirectly to junior CPP leaders.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, 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.Plan, conduct PK and PK/PD analyses and reporting.Prepare CP contributions to regulatory documents including briefing books, submission packages, responses to health authority questions, and other regulatory documents. Represent CPP in relevant external regulatory meetings (e.g., End of Phase 2, pre-NDA / MAA, Advisory Committee meetings).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 by engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.) and identify new opportunities for applied scientific and technical advancement within the department.Apply relevant technical trainings/learnings to daily responsibilities, with focus on value/impact. Where appropriate, serve as mentor/trainer for junior staff.Foster working environment that promotes collaboration, innovation, and creativity.Assist in process improvement initiatives and SOP development where applicable.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.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 and influence stakeholders.Has established a strong level of expertise and scientific reputation through multiple publications and presentations.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.Additional Information:This job posting is anticipated to close on July 17, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.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-New Jersey-RaritanOther Locations:
NA-United States, NA-US-Pennsylvania-Spring HouseJob Function:
Pharmacokinetics & Pharmacometrics
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Johnson 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.DescriptionThe 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. The Senior Principal Scientist CPP Leader is responsible and accountable for developing compound specific Clinical Pharmacology strategy for the development of a compound, including interactions with regulatory agencies and functions as CPP Leader on the Compound Development Teams (CDT) working in collaboration with various stakeholders within the team and within Quantitative Sciences (e.g., Statistics, Pharmacometrics). The Senior Principal Scientist CPP Leader can independently execute the day-to-day operations for the clinical pharmacology aspects of the assigned programs and may provide management directly or indirectly to junior CPP leaders.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, 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.Plan, conduct PK and PK/PD analyses and reporting.Prepare CP contributions to regulatory documents including briefing books, submission packages, responses to health authority questions, and other regulatory documents. Represent CPP in relevant external regulatory meetings (e.g., End of Phase 2, pre-NDA / MAA, Advisory Committee meetings).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 by engaging with the scientific community (e.g., publishing, presenting at meetings, participating in special interest groups within professional societies, etc.) and identify new opportunities for applied scientific and technical advancement within the department.Apply relevant technical trainings/learnings to daily responsibilities, with focus on value/impact. Where appropriate, serve as mentor/trainer for junior staff.Foster working environment that promotes collaboration, innovation, and creativity.Assist in process improvement initiatives and SOP development where applicable.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.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 and influence stakeholders.Has established a strong level of expertise and scientific reputation through multiple publications and presentations.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.Additional Information:This job posting is anticipated to close on July 17, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.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-New Jersey-RaritanOther Locations:
NA-United States, NA-US-Pennsylvania-Spring HouseJob Function:
Pharmacokinetics & Pharmacometrics
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