GlaxoSmithKline
Director, Clinical Pharmacology (QSP)
GlaxoSmithKline, Cambridge, Massachusetts, us, 02140
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 conferences.Develop a strategy for QSP integration and identify key points of impact into the workflow of clinical drug development.Identify 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 strategy.Scope those QSP opportunities for MID3, and gain engagement from the project team members and decision stakeholders.Serve 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 data.Lead 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 opportunities.Build 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 modalities.Ensure 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 stakeholders.Innovate 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 teams.Continually educate stakeholders on the advantages and limitations of QSP approaches, and promote MID3 by publishing in peer-reviewed journals and presenting at scientific conferences.Lead, guide, and supervise other QSP modelers.Why you?Basic Qualifications:PhD in Applied Mathematics, Engineering or Pharmaceutical Sciences.Experience in the application of mathematical and statistical methods.Experience in developing and applying QSP approaches to drug discovery and development programs in the pharmaceutical industry.Experience 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 systems.Computational 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, SAS.Experience in clinical pharmacology and its utility in drug development, including pharmacokinetics, pharmacodynamic and pharmacometrics approaches, and model-informed drug discovery & development.Experience with line management of junior scientists.Preferred Qualifications:Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills to develop mechanistically-sound PK-PD models.Understanding of PK-PD principles and commonly applied models.Ability to translate, condense, summarize outcomes of modeling and simulation analyses into information that can be understood and invested by project teams.Ability to keep up-to-date with and propose the implementation of scientific and technological developments in the area of mechanistic PK-PD.Knowledge of or ability to quickly learn the mechanisms, endpoints, disease understanding and treatment approaches in Oncology and other relevant therapy areas.Good listener and ability to effectively interact with colleagues with a variety of backgrounds.Self-directed, independent, and highly motivated researcher who excels in a collaborative, multi-disciplinary team environment.Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results.Ability to effectively multi-task and deliver results on time.Demonstrated expertise in drug discovery and development of novel oncology therapeutics.
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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 conferences.Develop a strategy for QSP integration and identify key points of impact into the workflow of clinical drug development.Identify 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 strategy.Scope those QSP opportunities for MID3, and gain engagement from the project team members and decision stakeholders.Serve 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 data.Lead 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 opportunities.Build 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 modalities.Ensure 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 stakeholders.Innovate 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 teams.Continually educate stakeholders on the advantages and limitations of QSP approaches, and promote MID3 by publishing in peer-reviewed journals and presenting at scientific conferences.Lead, guide, and supervise other QSP modelers.Why you?Basic Qualifications:PhD in Applied Mathematics, Engineering or Pharmaceutical Sciences.Experience in the application of mathematical and statistical methods.Experience in developing and applying QSP approaches to drug discovery and development programs in the pharmaceutical industry.Experience 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 systems.Computational 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, SAS.Experience in clinical pharmacology and its utility in drug development, including pharmacokinetics, pharmacodynamic and pharmacometrics approaches, and model-informed drug discovery & development.Experience with line management of junior scientists.Preferred Qualifications:Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills to develop mechanistically-sound PK-PD models.Understanding of PK-PD principles and commonly applied models.Ability to translate, condense, summarize outcomes of modeling and simulation analyses into information that can be understood and invested by project teams.Ability to keep up-to-date with and propose the implementation of scientific and technological developments in the area of mechanistic PK-PD.Knowledge of or ability to quickly learn the mechanisms, endpoints, disease understanding and treatment approaches in Oncology and other relevant therapy areas.Good listener and ability to effectively interact with colleagues with a variety of backgrounds.Self-directed, independent, and highly motivated researcher who excels in a collaborative, multi-disciplinary team environment.Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results.Ability to effectively multi-task and deliver results on time.Demonstrated expertise in drug discovery and development of novel oncology therapeutics.
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