GlaxoSmithKline
Director, Clinical Pharmacology Modeling and Simulation (CPMS)
GlaxoSmithKline, Waltham, Massachusetts, United States, 02254
Site Name:
USA - Massachusetts - Waltham, GSK HQ, Stevenage, USA - North Carolina - Durham, USA - Pennsylvania - Upper ProvidencePosted Date:
Sep 6 2024We have an exciting opportunity at GSK for a highly motivated and experienced director-level quantitative clinical pharmacologist to join our team supporting the oncology therapeutic area as part of the global Clinical Pharmacology Modelling and Simulation (CPMS) department. If you are energized by leveraging your clinical pharmacology and pharmacometrics experience to accelerate the development of oncology therapeutics this role may be for you.Job Purpose
As a Director of Clinical Pharmacology Modelling and Simulation (CPMS) you will be part of a large science driven team delivering clinical pharmacology and modelling & simulation excellence to research and development programs. You’ll have the opportunity to work on a wide diversity of therapeutic modalities including small molecules, biologics, and antibody-drug-conjugates in the Oncology Therapeutic Area. CPMS responsibilities generally commence post-lead optimization with accountability occurring from approximately 6 months prior to FTIH through to life cycle management.At GSK we are proud to combine both clinical pharmacology and modeling & simulation (M&S) accountabilities into one role aiming to bring the value of model-informed drug development to our R&D portfolio. GSK provides a supportive environment for scientists who are aspiring to learn, contribute and lead to make an impact on development decisions through innovation, expertise, and influence.Key responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:Contribute, as a member of a multi-disciplinary team, to the design of efficient clinical development programs and robust registration packagesPlay a central role in predicting human dose range, characterizing exposure-response relationship and justifying dose recommendations for later studies and for special populations.Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamicsDevelop mathematical models to understand disease, its progression, and drug pharmacodynamics and pharmacokinetics; conduct meta-analyses as appropriate to generate knowledge through data re-use; conduct simulations to assess trial design performancePresent the CPMS strategy and discuss outcome of model-based approaches via interactions with project teams, governance boards and regulatory agenciesWrite sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packagesProvide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategyAdvocate for the use of model-informed drug discovery and development (MID3) in teams and through external collaboration, journal publication and conference presentation.Innovate through working effectively with colleagues in the department and other matrix team members, including: development team leaders, statisticians, biologists, physicians and drug metabolism scientistsLearn and apply emerging modelling and simulation methodologies with a view to enhance clinical program efficiency and investment decision quality; collaborate with external field-leading teams for methodology application.Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:Advanced training with a degree such as PhD, PharmD and MD in Pharmaceutical Sciences, (Bio)Engineering, Mathematics, Statistics, Medicine or related field5+ years experience leveraging clinical pharmacology and modeling in drug development5+ years experience applying pharmacokinetic and pharmacodynamic principles and commonly applied pharmacometric models5+ years of experience utilizing tools for quantitative clinical pharmacology such as NONMEM, Monolix, R, SAS and/or MATLABExperience through previous roles in applying appropriate FDA and ICH guidelines in the design of clinical development plans and studiesPreferred Qualifications:
If you have the following characteristics, it would be a plus:Oncology drug development experience.Solid experience with advanced pharmacometric approaches such as tumor size kinetics and joint models, or model-based meta-analysis, or adaptive dosing simulations, and/or mechanistic PKPD modelingExperience in designing, analyzing and reporting clinical studies, with a simulation- or modelling-based approach where appropriateFamiliarity with M&S contributions to regulatory submission documentsKnowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of diseases in oncology.Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology resultsSound judgement, analytical mindset and problem-solving skillsAbility to effectively multi-task and deliver results on time
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USA - Massachusetts - Waltham, GSK HQ, Stevenage, USA - North Carolina - Durham, USA - Pennsylvania - Upper ProvidencePosted Date:
Sep 6 2024We have an exciting opportunity at GSK for a highly motivated and experienced director-level quantitative clinical pharmacologist to join our team supporting the oncology therapeutic area as part of the global Clinical Pharmacology Modelling and Simulation (CPMS) department. If you are energized by leveraging your clinical pharmacology and pharmacometrics experience to accelerate the development of oncology therapeutics this role may be for you.Job Purpose
As a Director of Clinical Pharmacology Modelling and Simulation (CPMS) you will be part of a large science driven team delivering clinical pharmacology and modelling & simulation excellence to research and development programs. You’ll have the opportunity to work on a wide diversity of therapeutic modalities including small molecules, biologics, and antibody-drug-conjugates in the Oncology Therapeutic Area. CPMS responsibilities generally commence post-lead optimization with accountability occurring from approximately 6 months prior to FTIH through to life cycle management.At GSK we are proud to combine both clinical pharmacology and modeling & simulation (M&S) accountabilities into one role aiming to bring the value of model-informed drug development to our R&D portfolio. GSK provides a supportive environment for scientists who are aspiring to learn, contribute and lead to make an impact on development decisions through innovation, expertise, and influence.Key responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:Contribute, as a member of a multi-disciplinary team, to the design of efficient clinical development programs and robust registration packagesPlay a central role in predicting human dose range, characterizing exposure-response relationship and justifying dose recommendations for later studies and for special populations.Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamicsDevelop mathematical models to understand disease, its progression, and drug pharmacodynamics and pharmacokinetics; conduct meta-analyses as appropriate to generate knowledge through data re-use; conduct simulations to assess trial design performancePresent the CPMS strategy and discuss outcome of model-based approaches via interactions with project teams, governance boards and regulatory agenciesWrite sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packagesProvide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategyAdvocate for the use of model-informed drug discovery and development (MID3) in teams and through external collaboration, journal publication and conference presentation.Innovate through working effectively with colleagues in the department and other matrix team members, including: development team leaders, statisticians, biologists, physicians and drug metabolism scientistsLearn and apply emerging modelling and simulation methodologies with a view to enhance clinical program efficiency and investment decision quality; collaborate with external field-leading teams for methodology application.Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:Advanced training with a degree such as PhD, PharmD and MD in Pharmaceutical Sciences, (Bio)Engineering, Mathematics, Statistics, Medicine or related field5+ years experience leveraging clinical pharmacology and modeling in drug development5+ years experience applying pharmacokinetic and pharmacodynamic principles and commonly applied pharmacometric models5+ years of experience utilizing tools for quantitative clinical pharmacology such as NONMEM, Monolix, R, SAS and/or MATLABExperience through previous roles in applying appropriate FDA and ICH guidelines in the design of clinical development plans and studiesPreferred Qualifications:
If you have the following characteristics, it would be a plus:Oncology drug development experience.Solid experience with advanced pharmacometric approaches such as tumor size kinetics and joint models, or model-based meta-analysis, or adaptive dosing simulations, and/or mechanistic PKPD modelingExperience in designing, analyzing and reporting clinical studies, with a simulation- or modelling-based approach where appropriateFamiliarity with M&S contributions to regulatory submission documentsKnowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of diseases in oncology.Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology resultsSound judgement, analytical mindset and problem-solving skillsAbility to effectively multi-task and deliver results on time
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