GSK

Quantitative System Pharmacology Lead

Employer
GSK
Location
Collegeville, Pennsylvania; Waltham, Massachusetts; Research Triangle Park, North Carolina; Philadelphia, Pennsylvania
Salary
Competitive
Posted
September 24 2021
Ref
289844
Organization Type
Pharma
Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham, USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Philadelphia Posted Date: Sep 24 2021 Quantitative System Pharmacology Lead We are seeking a Director-level Immunology, Inflammation, Infectious Disease and Opportunity-Driven Areas 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 develop a deeper understanding of physiological systems and disease mechanisms within and across therapeutic areas. A successful candidate comes with passion and curiosity and works collaboratively in multidisciplinary teams and with QSP modelers internally and externally. Role Responsibilities: 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 multidisciplinary 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; develop a deep disease understanding and knowledge base Create a collaboration framework with internal and external experts in the development and application of these models Learn and apply emerging modeling and simulation methodologies with a view to enhance clinical program efficiency and investment decision quality; collaborate with external field-leading teams for methodology application 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 Explore and build new QSP opportunities and synergies in combining QSP approaches with other computational groups including human genetics and functional genomics Provide both scientific and strategic expertise across multiple (non-oncology) therapeutic areas to facilitate, develop and deliver quantitative support for decision making in critical clinical development program questions, as well as contribute to design and execution of quantitative mechanistic models to support clinical programs Oversee and guide the scientific rigor and biological suitability 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) Potentially lead, guide, and supervise other QSP modelers 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) Assess impact of DDI's and special populations on drug exposure to inform label (using in silico PBPK modeling approaches where possible) Undertake early comparative benchmarking of compound activity relative to competitors and the target medicine profile using model-based meta-analysis (MBMA) 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: Advanced degree such as PhD in Applied Mathematics, Engineering, Pharmaceutical Sciences, Systems Biology, or related disciplines with strong background in the application of mathematical and statistical methods Demonstrated experience (4-10 years in industry) in developing and applying QSP approaches to drug discovery and development programs in the pharmaceutical industry Deep understanding of 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 fluency and extensive, hands-on experience with one or more modeling and simulation packages or programming languages (e.g., MATLAB, R, Julia, SimBiology, C/C++) Working knowledge of common tools for quantitative clinical pharmacology such as NONMEM, R, WINNONLIN, Simcyp, SAS 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 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 Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk Managing individual and team change.performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. CPMS_US_UK *LI-GSK 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/ Agencies GSK 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.

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