J&J Family of Companies
Senior Principal Scientist, Pharmacometrics Leader
J&J Family of Companies, Augusta, Maine, us, 04338
J&J Family of Companies Senior Principal Scientist, Pharmacometrics Leader - Augusta, Maine
Senior Principal Scientist, Pharmacometrics Leader - 2406193490WDescriptionJohnson 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.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at
https://www.jnj.com/ .For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities, and experiences are valued and our people can reach their potential.At Johnson & Johnson, we all belong.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. 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.Carries out functional responsibilities in accordance with applicable SOPs, regulatory requirements, and Johnson & Johnson Credo principles.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 the overall drug development process, including regulatory guidance, and methods in modeling 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 training/learnings to daily responsibilities, with a focus on value/impact. Where appropriate, serve as a mentor/trainer for junior staff.Foster a 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 a related field required.PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 6 years of experience in pharmaceutical, biomedical, or a 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 the 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 the 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.Location:Primary Location: NA-US-New Jersey-RaritanOther Locations: NA-United States, NA-US-Pennsylvania-Spring HouseJob Function:
Pharmacokinetics & Pharmacometrics
#J-18808-Ljbffr
Senior Principal Scientist, Pharmacometrics Leader - 2406193490WDescriptionJohnson 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.At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at
https://www.jnj.com/ .For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities, and experiences are valued and our people can reach their potential.At Johnson & Johnson, we all belong.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. 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.Carries out functional responsibilities in accordance with applicable SOPs, regulatory requirements, and Johnson & Johnson Credo principles.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 the overall drug development process, including regulatory guidance, and methods in modeling 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 training/learnings to daily responsibilities, with a focus on value/impact. Where appropriate, serve as a mentor/trainer for junior staff.Foster a 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 a related field required.PhD in Pharmaceutical Sciences, Clinical Pharmacology, Biomedical Engineering, or relevant Biological Sciences, with 6 years of experience in pharmaceutical, biomedical, or a 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 the 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 the 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.Location:Primary Location: NA-US-New Jersey-RaritanOther Locations: NA-United States, NA-US-Pennsylvania-Spring HouseJob Function:
Pharmacokinetics & Pharmacometrics
#J-18808-Ljbffr