GlaxoSmithKline
Associate Director, Quantitative Systems Pharmacology
GlaxoSmithKline, Collegeville, Pennsylvania, United States, 19426
Overview
The Department of Clinical Pharmacology & Pharmacometrics, Systems and Tools at GSK is recruiting for an Associate Director level Quantitative Systems Pharmacologist, with a robust background in HIV and Vaccines. Preferred site locations: Stevenage, UK; Collegeville, PA, USA; Durham, NC, USA; Cambridge, MA, USA. This position requires a PhD, MD, PharmD or equivalent doctoral background, with experience as a mathematical modeller who will use Quantitative Systems Pharmacology, mathematical modelling, and computational skills together with Pharmacometrics to advance GSK/ViiV’s HIV & Vaccines portfolio. Experience in building and integrating mechanistic mathematical models and disease platforms with advanced analytical techniques (such as in-silico trial frameworks and scientific machine learning) to enhance decision-making from exploratory research, translation, clinical development, registration, and lifecycle management is sought. At GSK we develop therapies of various modalities for a broad range of indications. Responsibilities commence at candidate selection stage with preparations for first-in-human trials and continue through filing, registration, and market expansion. As a member of a global department with diverse expertise, you will enjoy a highly supportive environment for scientific innovation, business impact and professional growth. Our work supports GSK’s mission to help patients feel better and live longer by getting ahead of disease together. Key Responsibilities
The key responsibilities and accountabilities comprise both modelling/simulation activities and clinical pharmacology leadership and include: Build, develop, or utilize mechanistic models of biological, physiological, and pathophysiological processes to evaluate disease pathways and progression, as well as drug candidates or treatment modalities; conduct simulations to generate virtual patients for in-silico trials to optimize clinical trial design; conduct meta-analyses as appropriate to generate knowledge through data reuse. Develop or utilize state-of-the-art mathematical and clinical pharmacology tools to gain insight into causal relationships between components of system-level and drug-level responses of drug-target-biomarker-disease-patient interaction. Contribute to clinical program design and dosing regimen selection, trial protocols, translational and disease-area strategies, analysis plans, study reports, regulatory submissions, and due diligence for business development as appropriate. Work in close collaboration with biologists/virologists, clinicians, clinical pharmacologists, pharmacometricians, statisticians and other partner line colleagues to inform research and development programs and improve understanding of disease mechanisms. Learn and apply emerging modelling and simulation methodologies to enhance clinical program efficiency and investment decision quality; implement best practices and lessons learned to further clinical pharmacology modelling contributions to the R&D pipeline. Present strategy and defend outcomes of model-based approaches to internal governance boards and regulatory agencies. Promote Model-Informed Drug Discovery and Development (MID3) through external presentations at international conferences and publications in peer-reviewed scientific journals. Why you?
Qualifications
We are looking for professionals with these required skills to achieve our goals: PhD, MD, or PharmD required. 5+ years’ experience in clinical pharmacology, modelling and simulation in pharmaceutical research and development. Experience in utilizing mechanistic mathematical modelling and simulation (QSP, PKPD, etc.) to answer questions in drug discovery and development to solve practical problems in industry and/or academia. Experience with mechanisms, endpoints, progression, prevention, and treatments for Vaccines and Infectious Diseases (with a focus on HIV). Experience with implementation of model-informed drug development approaches to improve clinical trial success and accelerate patient access to novel therapies. Preferred Skills & Qualifications
If you have the following characteristics, it would be a plus: A doctorate that is relevant to Quantitative Systems Pharmacology (e.g., Mathematics, Engineering, Physics, Systems Biology, Mathematical Modelling, etc.). Consistently achieved on-time delivery rate for project milestones by collaborating with a multi-discipline team and effectively communicating with key stakeholders in a cross-functional environment. Ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks. Passion for Quantitative Clinical Pharmacology and a desire to innovate for better outcomes. Prior experience in clinical QSP, popPK/PD, and virus dynamics modelling as well as virtual patients and in silico trials within infectious diseases (HIV in particular) and Vaccines in an industry setting. Experience with relevant modalities (small molecule antivirals, monoclonal broadly neutralizing antibodies, bispecific antibodies, mRNA vaccines, adjuvanted protein vaccines, immune-activating agents) would be a plus. Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design. Strong publication record in peer-reviewed journals. Please note this job description may not be available post-closure of the advert. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We are committed to creating an environment where our people can thrive and focus on what matters most, guided by our values of ambition for patients, accountability for impact and doing the right thing. If you require an accommodation or other assistance to apply for a job, 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. This ensures that all qualified applicants receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under applicable law. Please note that if you are a US Licensed Healthcare Professional, GSK may be required to capture and report expenses for compliance with transparency requirements. For more information, please visit the CMS Open Payments data site.
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The Department of Clinical Pharmacology & Pharmacometrics, Systems and Tools at GSK is recruiting for an Associate Director level Quantitative Systems Pharmacologist, with a robust background in HIV and Vaccines. Preferred site locations: Stevenage, UK; Collegeville, PA, USA; Durham, NC, USA; Cambridge, MA, USA. This position requires a PhD, MD, PharmD or equivalent doctoral background, with experience as a mathematical modeller who will use Quantitative Systems Pharmacology, mathematical modelling, and computational skills together with Pharmacometrics to advance GSK/ViiV’s HIV & Vaccines portfolio. Experience in building and integrating mechanistic mathematical models and disease platforms with advanced analytical techniques (such as in-silico trial frameworks and scientific machine learning) to enhance decision-making from exploratory research, translation, clinical development, registration, and lifecycle management is sought. At GSK we develop therapies of various modalities for a broad range of indications. Responsibilities commence at candidate selection stage with preparations for first-in-human trials and continue through filing, registration, and market expansion. As a member of a global department with diverse expertise, you will enjoy a highly supportive environment for scientific innovation, business impact and professional growth. Our work supports GSK’s mission to help patients feel better and live longer by getting ahead of disease together. Key Responsibilities
The key responsibilities and accountabilities comprise both modelling/simulation activities and clinical pharmacology leadership and include: Build, develop, or utilize mechanistic models of biological, physiological, and pathophysiological processes to evaluate disease pathways and progression, as well as drug candidates or treatment modalities; conduct simulations to generate virtual patients for in-silico trials to optimize clinical trial design; conduct meta-analyses as appropriate to generate knowledge through data reuse. Develop or utilize state-of-the-art mathematical and clinical pharmacology tools to gain insight into causal relationships between components of system-level and drug-level responses of drug-target-biomarker-disease-patient interaction. Contribute to clinical program design and dosing regimen selection, trial protocols, translational and disease-area strategies, analysis plans, study reports, regulatory submissions, and due diligence for business development as appropriate. Work in close collaboration with biologists/virologists, clinicians, clinical pharmacologists, pharmacometricians, statisticians and other partner line colleagues to inform research and development programs and improve understanding of disease mechanisms. Learn and apply emerging modelling and simulation methodologies to enhance clinical program efficiency and investment decision quality; implement best practices and lessons learned to further clinical pharmacology modelling contributions to the R&D pipeline. Present strategy and defend outcomes of model-based approaches to internal governance boards and regulatory agencies. Promote Model-Informed Drug Discovery and Development (MID3) through external presentations at international conferences and publications in peer-reviewed scientific journals. Why you?
Qualifications
We are looking for professionals with these required skills to achieve our goals: PhD, MD, or PharmD required. 5+ years’ experience in clinical pharmacology, modelling and simulation in pharmaceutical research and development. Experience in utilizing mechanistic mathematical modelling and simulation (QSP, PKPD, etc.) to answer questions in drug discovery and development to solve practical problems in industry and/or academia. Experience with mechanisms, endpoints, progression, prevention, and treatments for Vaccines and Infectious Diseases (with a focus on HIV). Experience with implementation of model-informed drug development approaches to improve clinical trial success and accelerate patient access to novel therapies. Preferred Skills & Qualifications
If you have the following characteristics, it would be a plus: A doctorate that is relevant to Quantitative Systems Pharmacology (e.g., Mathematics, Engineering, Physics, Systems Biology, Mathematical Modelling, etc.). Consistently achieved on-time delivery rate for project milestones by collaborating with a multi-discipline team and effectively communicating with key stakeholders in a cross-functional environment. Ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks. Passion for Quantitative Clinical Pharmacology and a desire to innovate for better outcomes. Prior experience in clinical QSP, popPK/PD, and virus dynamics modelling as well as virtual patients and in silico trials within infectious diseases (HIV in particular) and Vaccines in an industry setting. Experience with relevant modalities (small molecule antivirals, monoclonal broadly neutralizing antibodies, bispecific antibodies, mRNA vaccines, adjuvanted protein vaccines, immune-activating agents) would be a plus. Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design. Strong publication record in peer-reviewed journals. Please note this job description may not be available post-closure of the advert. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We are committed to creating an environment where our people can thrive and focus on what matters most, guided by our values of ambition for patients, accountability for impact and doing the right thing. If you require an accommodation or other assistance to apply for a job, 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. This ensures that all qualified applicants receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under applicable law. Please note that if you are a US Licensed Healthcare Professional, GSK may be required to capture and report expenses for compliance with transparency requirements. For more information, please visit the CMS Open Payments data site.
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