GlaxoSmithKline
Director, Clinical Pharmacology (QSP)
GlaxoSmithKline, Collegeville, Pennsylvania, United States, 19426
Site Name:
USA - Pennsylvania - Upper Providence, Cambridge MA, GSK HQ, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham, USA - North Carolina - Carolinas, WalthamPosted Date:
Aug 23 2024We have an exciting opportunity at GSK for a highly motivated and experienced Director level Quantitative Systems Pharmacology (QSP) Expert to join our team supporting oncology therapeutic area as part of the global Clinical Pharmacology Modelling and Simulation (CPMS) department. Delivering CPMS excellence to research and development programs using quantitative pharmacology approaches, as part of the model-informed drug discovery & development paradigm (MID3), to get innovative oncology therapies faster to the right patients at the right dose.JOB PURPOSE:As a Director-level Quantitative Systems Pharmacology (QSP) Expert, you will develop, guide and apply QSP models to guide clinical study designs and mechanistic interpretation of study results in support of development of treatments and combination of treatments for a variety of diseases and therapeutic areas.The Director QSP Expert will also be responsible for integrating and sharing data and knowledge in a highly stimulating, collaborative, and multi-disciplinary environment to develop a deeper understanding of physiological systems and disease mechanisms within and across therapeutic areas.In this role you will have the opportunity to bring the value of mechanistic models to the clinical evaluation of new and exciting drug modalities, therapeutic combinations, and patient stratification hypotheses in our diverse Oncology R&D portfolio. A successful candidate comes with passion and curiosity and works collaboratively in multidisciplinary teams and with QSP modelers internally and externally.This position requires an on-site office presence for 2-3 days per week in any of GSK’s UK or US sites; a remote role may be possible for the right candidate.This role will provide YOU the opportunity to contribute and lead key activities to progress YOUR career, these responsibilities include some of the following:Promote model-informed drug discovery & development (MID3) strategies and approaches by publishing in peer-reviewed journals and presenting at scientific conferencesDevelop a strategy for QSP integration and identify key points of impact into the workflow of clinical drug developmentIdentify opportunities in collaboration with the CPMS Project Leads where QSP and mechanistic modeling approaches can bring a unique angle to inform project decisions and address project questions in alignment with the CPMS MID3 strategyScope those QSP opportunities for MID3, and gain engagement from the project team members and decision stakeholdersServe as QSP modeling & simulation point-of-contact in multidisciplinary project teams to solve challenging problems in drug research and development; contribute to preclinical and clinical study design and mechanistic interpretation of dataLead internal or external modelers, biologists, statisticians, and clinical colleagues towards the development of qualified QSP models that can address the questions and decisions at the center of those opportunitiesBuild and utilize QSP models of biological, physiological, and pathophysiological processes to evaluate a disease, its pathways and progression, as well as drug candidates or treatment modalitiesEnsure that QSP simulations and analyses can be translated into actionable insights, learnings, or recommendations for the clinical project team, and communicate those effectively to the project team members and decision stakeholdersInnovate by keeping abreast of emerging modelling and simulation methodologies, participating actively in internal and external QSP professional community events and initiatives, and seeking diversity of thought within interdisciplinary teamsContinually educate stakeholders on the advantages and limitations of QSP approaches, and promote MID3 by publishing in peer-reviewed journals and presenting at scientific conferencesLead, guide, and supervise other QSP modelersWhy you?Basic Qualifications:PhD in Applied Mathematics, Engineering or Pharmaceutical SciencesExperience in the application of mathematical and statistical methodsExperience in developing and applying QSP approaches to drug discovery and development programs in the pharmaceutical industryExperience in theory, principles, and statistical aspects of mathematical modeling and simulation, including numerical methods, parameter estimation/optimization, ordinary differential equations (ODEs), and how these can be applied in the development of complex models of biological pathways and systemsComputational and hands-on experience with one or more modeling and simulation packages or programming languages (e.g., MATLAB, R, Julia, SimBiology, C/C++)Experience of common tools for quantitative clinical pharmacology such as NONMEM, R, WINNONLIN, Simcyp, SASExperience in clinical pharmacology and its utility in drug development, including pharmacokinetics, pharmacodynamic and pharmacometrics approaches, and model-informed drug discovery & developmentExperience with line management of junior scientistsPreferred Qualifications:Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills to develop mechanistically-sound PK-PD modelsUnderstanding of PK-PD principles and commonly applied modelsAbility to translate, condense, summarize outcomes of modeling and simulation analyses into information that can be understood and invested by project teamsAbility to keep up-to-date with and propose the implementation of scientific and technological developments in the area of mechanistic PK-PDKnowledge of or ability to quickly learn the mechanisms, endpoints, disease understanding and treatment approaches in Oncology and other relevant therapy areasGood listener and ability to effectively interact with colleagues with a variety of backgroundsSelf-directed, independent, and highly motivated researcher who excels in a collaborative, multi-disciplinary team environmentAbility to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology resultsAbility to effectively multi-task and deliver results on timeDemonstrated expertise in drug discovery and development of novel oncology therapeuticsGSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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USA - Pennsylvania - Upper Providence, Cambridge MA, GSK HQ, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham, USA - North Carolina - Carolinas, WalthamPosted Date:
Aug 23 2024We have an exciting opportunity at GSK for a highly motivated and experienced Director level Quantitative Systems Pharmacology (QSP) Expert to join our team supporting oncology therapeutic area as part of the global Clinical Pharmacology Modelling and Simulation (CPMS) department. Delivering CPMS excellence to research and development programs using quantitative pharmacology approaches, as part of the model-informed drug discovery & development paradigm (MID3), to get innovative oncology therapies faster to the right patients at the right dose.JOB PURPOSE:As a Director-level Quantitative Systems Pharmacology (QSP) Expert, you will develop, guide and apply QSP models to guide clinical study designs and mechanistic interpretation of study results in support of development of treatments and combination of treatments for a variety of diseases and therapeutic areas.The Director QSP Expert will also be responsible for integrating and sharing data and knowledge in a highly stimulating, collaborative, and multi-disciplinary environment to develop a deeper understanding of physiological systems and disease mechanisms within and across therapeutic areas.In this role you will have the opportunity to bring the value of mechanistic models to the clinical evaluation of new and exciting drug modalities, therapeutic combinations, and patient stratification hypotheses in our diverse Oncology R&D portfolio. A successful candidate comes with passion and curiosity and works collaboratively in multidisciplinary teams and with QSP modelers internally and externally.This position requires an on-site office presence for 2-3 days per week in any of GSK’s UK or US sites; a remote role may be possible for the right candidate.This role will provide YOU the opportunity to contribute and lead key activities to progress YOUR career, these responsibilities include some of the following:Promote model-informed drug discovery & development (MID3) strategies and approaches by publishing in peer-reviewed journals and presenting at scientific conferencesDevelop a strategy for QSP integration and identify key points of impact into the workflow of clinical drug developmentIdentify opportunities in collaboration with the CPMS Project Leads where QSP and mechanistic modeling approaches can bring a unique angle to inform project decisions and address project questions in alignment with the CPMS MID3 strategyScope those QSP opportunities for MID3, and gain engagement from the project team members and decision stakeholdersServe as QSP modeling & simulation point-of-contact in multidisciplinary project teams to solve challenging problems in drug research and development; contribute to preclinical and clinical study design and mechanistic interpretation of dataLead internal or external modelers, biologists, statisticians, and clinical colleagues towards the development of qualified QSP models that can address the questions and decisions at the center of those opportunitiesBuild and utilize QSP models of biological, physiological, and pathophysiological processes to evaluate a disease, its pathways and progression, as well as drug candidates or treatment modalitiesEnsure that QSP simulations and analyses can be translated into actionable insights, learnings, or recommendations for the clinical project team, and communicate those effectively to the project team members and decision stakeholdersInnovate by keeping abreast of emerging modelling and simulation methodologies, participating actively in internal and external QSP professional community events and initiatives, and seeking diversity of thought within interdisciplinary teamsContinually educate stakeholders on the advantages and limitations of QSP approaches, and promote MID3 by publishing in peer-reviewed journals and presenting at scientific conferencesLead, guide, and supervise other QSP modelersWhy you?Basic Qualifications:PhD in Applied Mathematics, Engineering or Pharmaceutical SciencesExperience in the application of mathematical and statistical methodsExperience in developing and applying QSP approaches to drug discovery and development programs in the pharmaceutical industryExperience in theory, principles, and statistical aspects of mathematical modeling and simulation, including numerical methods, parameter estimation/optimization, ordinary differential equations (ODEs), and how these can be applied in the development of complex models of biological pathways and systemsComputational and hands-on experience with one or more modeling and simulation packages or programming languages (e.g., MATLAB, R, Julia, SimBiology, C/C++)Experience of common tools for quantitative clinical pharmacology such as NONMEM, R, WINNONLIN, Simcyp, SASExperience in clinical pharmacology and its utility in drug development, including pharmacokinetics, pharmacodynamic and pharmacometrics approaches, and model-informed drug discovery & developmentExperience with line management of junior scientistsPreferred Qualifications:Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills to develop mechanistically-sound PK-PD modelsUnderstanding of PK-PD principles and commonly applied modelsAbility to translate, condense, summarize outcomes of modeling and simulation analyses into information that can be understood and invested by project teamsAbility to keep up-to-date with and propose the implementation of scientific and technological developments in the area of mechanistic PK-PDKnowledge of or ability to quickly learn the mechanisms, endpoints, disease understanding and treatment approaches in Oncology and other relevant therapy areasGood listener and ability to effectively interact with colleagues with a variety of backgroundsSelf-directed, independent, and highly motivated researcher who excels in a collaborative, multi-disciplinary team environmentAbility to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology resultsAbility to effectively multi-task and deliver results on timeDemonstrated expertise in drug discovery and development of novel oncology therapeuticsGSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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