GlaxoSmithKline
Associate Director, Quantitative Systems Pharmacology Lead
GlaxoSmithKline, Waltham, Massachusetts, United States, 02254
Site Name:
USA - Massachusetts - Waltham, USA - North Carolina - DurhamPosted Date:
Nov 7 2024We are seeking an
Associate Director level, Quantitative Systems Pharmacology Lead
for our Clinical Pharmacology Modelling and Simulation (CPMS) department.Quantitative Systems Pharmacology (QSP) is a discipline that uses mechanistic mathematical models and disease platforms to enhance the robustness and quality of decision-making from exploratory research through clinical development. We are seeking a highly motivated individual to develop 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 successful candidate will be responsible for integrating and sharing data and knowledge in a highly stimulating, collaborative, and multi-disciplinary environment to influence clinical study decisions and develop a deeper understanding of physiological systems and disease mechanisms within oncology.A successful candidate comes with passion and curiosity and works collaboratively in multidisciplinary teams and with QSP modelers internally and externally.Role Responsibilities:This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.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
Work in close collaboration with biologists, clinicians, clinical pharmacologists, pharmacometricians, QSP and nonclinical modelers, and other partner line colleagues to inform research and development programs and improve our understanding of disease mechanisms
Serve as QSP modeling & simulation point-of-contact in on project teams to solve challenging problems in drug research and development; contribute to preclinical and clinical study design and mechanistic interpretation of data
Develop and/or utilize state-of-the-art mathematical tools to gain insight into causal relationships between individual components of system-level and drug-level responses of drug-target-biomarker-disease-patient interaction
Analyze and interpret complex data sets in the context of disease mechanisms and pathways
Explore new QSP opportunities in combining QSP with other analytical approaches and build synergies through collaboration with computational groups including human genetics and functional genomics
Provide both scientific and strategic expertise in oncology therapeutic area to facilitate, develop and deliver quantitative support for decision making in clinical development programs
Perform scientific rigor and biological suitability assessment of QSP models and methodologies through establishing a context-driven verification & validation process (reviewing QSP model goals, assumptions, methodology, model code, model outputs, uncertainty quantification)
CPMS is a science driven group delivering clinical pharmacology modelling & simulation excellence to research and development programs. We use quantitative pharmacology approaches, as part of the model-informed drug discovery & development paradigm (MID3), to evolve understanding of compound behavior and optimize dose across the research and development continuum, delivering a competitive label for a filing. Our activities include:Advise on dose, regimen and study design to optimize understanding of compound characteristics and variability in exposure and response across all drug development phases.
Provide insights to programs through mechanistic modeling of drug-target-biomarker-disease-patient interaction (QSP modeling)
Identify opportunities to re-use clinical data to extrapolate to untested scenarios, avoiding unnecessary additional clinical trials.
Basic Qualifications:We are looking for professionals with these required skills to achieve our goals :PhD in Applied Mathematics, Engineering, Pharmaceutical Sciences, Systems Biology, or related disciplines with experience in the application of mathematical and statistical methods
2 or more years of experience in Pharma Life Science Biomedical industry developing and applying QSP approaches to drug development programs
Experience working with the theory, principles, 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 experience with one or more modeling and simulation packages or programming languages (e.g., MATLAB, R, Julia, SimBiology, C/C++)
Experience working with common tools for quantitative clinical pharmacology (such as NONMEM, R, WINNONLIN, Simcyp, SAS)
Experience developing mechanistically-sound PK-PD models
Experience translating, condensing, summarizing outcomes of modeling and simulation analyses into information that can be understood by project teams
Preferred Qualifications:If you have the following characteristics, it would be a plus:Demonstrated collaborative ways of working and able to work successfully in matrix teams
Ability to effectively communicate and interact with key stakeholders, medical professionals and senior leadership
Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills
#LI-GSKPlease visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK 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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
USA - Massachusetts - Waltham, USA - North Carolina - DurhamPosted Date:
Nov 7 2024We are seeking an
Associate Director level, Quantitative Systems Pharmacology Lead
for our Clinical Pharmacology Modelling and Simulation (CPMS) department.Quantitative Systems Pharmacology (QSP) is a discipline that uses mechanistic mathematical models and disease platforms to enhance the robustness and quality of decision-making from exploratory research through clinical development. We are seeking a highly motivated individual to develop 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 successful candidate will be responsible for integrating and sharing data and knowledge in a highly stimulating, collaborative, and multi-disciplinary environment to influence clinical study decisions and develop a deeper understanding of physiological systems and disease mechanisms within oncology.A successful candidate comes with passion and curiosity and works collaboratively in multidisciplinary teams and with QSP modelers internally and externally.Role Responsibilities:This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.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
Work in close collaboration with biologists, clinicians, clinical pharmacologists, pharmacometricians, QSP and nonclinical modelers, and other partner line colleagues to inform research and development programs and improve our understanding of disease mechanisms
Serve as QSP modeling & simulation point-of-contact in on project teams to solve challenging problems in drug research and development; contribute to preclinical and clinical study design and mechanistic interpretation of data
Develop and/or utilize state-of-the-art mathematical tools to gain insight into causal relationships between individual components of system-level and drug-level responses of drug-target-biomarker-disease-patient interaction
Analyze and interpret complex data sets in the context of disease mechanisms and pathways
Explore new QSP opportunities in combining QSP with other analytical approaches and build synergies through collaboration with computational groups including human genetics and functional genomics
Provide both scientific and strategic expertise in oncology therapeutic area to facilitate, develop and deliver quantitative support for decision making in clinical development programs
Perform scientific rigor and biological suitability assessment of QSP models and methodologies through establishing a context-driven verification & validation process (reviewing QSP model goals, assumptions, methodology, model code, model outputs, uncertainty quantification)
CPMS is a science driven group delivering clinical pharmacology modelling & simulation excellence to research and development programs. We use quantitative pharmacology approaches, as part of the model-informed drug discovery & development paradigm (MID3), to evolve understanding of compound behavior and optimize dose across the research and development continuum, delivering a competitive label for a filing. Our activities include:Advise on dose, regimen and study design to optimize understanding of compound characteristics and variability in exposure and response across all drug development phases.
Provide insights to programs through mechanistic modeling of drug-target-biomarker-disease-patient interaction (QSP modeling)
Identify opportunities to re-use clinical data to extrapolate to untested scenarios, avoiding unnecessary additional clinical trials.
Basic Qualifications:We are looking for professionals with these required skills to achieve our goals :PhD in Applied Mathematics, Engineering, Pharmaceutical Sciences, Systems Biology, or related disciplines with experience in the application of mathematical and statistical methods
2 or more years of experience in Pharma Life Science Biomedical industry developing and applying QSP approaches to drug development programs
Experience working with the theory, principles, 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 experience with one or more modeling and simulation packages or programming languages (e.g., MATLAB, R, Julia, SimBiology, C/C++)
Experience working with common tools for quantitative clinical pharmacology (such as NONMEM, R, WINNONLIN, Simcyp, SAS)
Experience developing mechanistically-sound PK-PD models
Experience translating, condensing, summarizing outcomes of modeling and simulation analyses into information that can be understood by project teams
Preferred Qualifications:If you have the following characteristics, it would be a plus:Demonstrated collaborative ways of working and able to work successfully in matrix teams
Ability to effectively communicate and interact with key stakeholders, medical professionals and senior leadership
Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills
#LI-GSKPlease visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK 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.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.