Reference #: 410588 Site Name: USA - Pennsylvania - Upper Providence Posted Date: Dec 5 2024

We 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 a e 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 Please 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.

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