GlaxoSmithKline
Associate Director, Clinical Pharmacology
GlaxoSmithKline, Durham, North Carolina, United States, 27703
Site Name:
USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham, USA - North Carolina - DurhamPosted Date:
Aug 28 2024GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human genetics and advanced technologies, such as functional genomics and AI/ML.We have an exciting opportunity at GSK for a highly motivated and experienced quantitative clinical pharmacologist to join our team supporting oncology therapeutic area as part of the global Clinical Pharmacology Modelling and Simulation (CPMS) department.As an Associate Director, CPMS, you will be part of a science driven group delivering clinical pharmacology and modelling & simulation excellence to research and development programs. You’ll have the opportunity to work on small molecules, biologics, and antibody drug conjugates in the Oncology therapeutic area. Responsibilities generally commence post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to life cycle management.This role will provide YOU the opportunity to contribute and lead key activities to progress YOUR career, these responsibilities include some of the following:Planning, conducting and reporting drug-disease modelling, exposure-response analysis, simulation-based trial design and dose selection, and population clinical pharmacology modellingApplying innovative methods such as longitudinal exposure-response analysis, model-based meta-analysis and quantitative systems pharmacology to enhance data use and trial efficiencyPresenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agenciesContributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissionsWrite or review clinical pharmacology components of regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labelling (with regards to the clinical pharmacology, modelling and simulation contents)Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipelineAbility to interact with line and middle management, staff and external contacts on a functional, strategic and tactical levelPromoting model-informed drug discovery and development through external collaboration, journal publication and conference presentationWhy you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:A doctorate (PharmD, PhD, MD) in Quantitative Clinical Pharmacology and Pharmacometrics disciplines (e.g., pharmacology, engineering or statistics) and experience in using modelling/simulation to solve practical problems in industry or academia2+ years of utilizing skills in mechanistic PKPD and longitudinal disease modelling; and verifiable proficiency in pharmacometric tools NONMEM, Monolix, R or SAS2+ years of experience in the design, analysis, interpretation and reporting of Clinical Pharmacology studies per industry and regulatory standards.Preferred Qualifications:If you have the following characteristics, it would be a plus:Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial designKnowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of cancersDemonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of resultsClear evidence of ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasksPassion for quantitative clinical pharmacology and desire to innovate for better outcomePrior experience in Oncology Research and Development is a plusExperience working with senior stakeholders in a cross functional environmentStrong track record of implementation of Model-Informed Drug Discovery and Development (MID3) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs
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USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham, USA - North Carolina - DurhamPosted Date:
Aug 28 2024GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human genetics and advanced technologies, such as functional genomics and AI/ML.We have an exciting opportunity at GSK for a highly motivated and experienced quantitative clinical pharmacologist to join our team supporting oncology therapeutic area as part of the global Clinical Pharmacology Modelling and Simulation (CPMS) department.As an Associate Director, CPMS, you will be part of a science driven group delivering clinical pharmacology and modelling & simulation excellence to research and development programs. You’ll have the opportunity to work on small molecules, biologics, and antibody drug conjugates in the Oncology therapeutic area. Responsibilities generally commence post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to life cycle management.This role will provide YOU the opportunity to contribute and lead key activities to progress YOUR career, these responsibilities include some of the following:Planning, conducting and reporting drug-disease modelling, exposure-response analysis, simulation-based trial design and dose selection, and population clinical pharmacology modellingApplying innovative methods such as longitudinal exposure-response analysis, model-based meta-analysis and quantitative systems pharmacology to enhance data use and trial efficiencyPresenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agenciesContributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissionsWrite or review clinical pharmacology components of regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labelling (with regards to the clinical pharmacology, modelling and simulation contents)Implement best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipelineAbility to interact with line and middle management, staff and external contacts on a functional, strategic and tactical levelPromoting model-informed drug discovery and development through external collaboration, journal publication and conference presentationWhy you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:A doctorate (PharmD, PhD, MD) in Quantitative Clinical Pharmacology and Pharmacometrics disciplines (e.g., pharmacology, engineering or statistics) and experience in using modelling/simulation to solve practical problems in industry or academia2+ years of utilizing skills in mechanistic PKPD and longitudinal disease modelling; and verifiable proficiency in pharmacometric tools NONMEM, Monolix, R or SAS2+ years of experience in the design, analysis, interpretation and reporting of Clinical Pharmacology studies per industry and regulatory standards.Preferred Qualifications:If you have the following characteristics, it would be a plus:Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial designKnowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of cancersDemonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of resultsClear evidence of ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasksPassion for quantitative clinical pharmacology and desire to innovate for better outcomePrior experience in Oncology Research and Development is a plusExperience working with senior stakeholders in a cross functional environmentStrong track record of implementation of Model-Informed Drug Discovery and Development (MID3) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs
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