PK/PD Modeller, Quantitative Pharmacology - Stevenage, UK

Job description

Details:
It has been widely published that the lack of biological efficacy remains a root cause of attrition in the clinic. As discovery of new therapeutic approaches for diseases with unmet medical need becomes more challenging, there is a need for a systematic application of Quantitative pharmacology principles. Underpinning this approach is a model based drug discovery framework applying appropriate PK, PBPK and PKPD analysis and simulation techniques to guide target selection, establish desired efficacy and safety profiles and the prediction of human dose.

GSK is committed to embedding a model based drug discovery framework impacting the design and selection of our future candidate molecules. A key component of this strategy is establishing a network of expert non-clinical scientists bringing together PBPK and PKPD skills and to drive and apply Quantitative Pharmacology under one Community of Practice.

Working in a dynamic and multidisciplinary environment the successful applicants will build on our current PBPK, PKPD knowledge to develop excellence in Quantitative Pharmacology facilitating improved decision making based on a deeper understanding of concentration-effect relationships in lead optimisation programmes. Successful applicants are to contribute to activities including target selection, molecule identification, experimental design, integrated efficacy and safety evaluation, dose prediction, biomarker selection and clinical trial design delivering higher quality molecules.

The successful applicant may work across a variety of therapeutic areas covering a range of modalities e.g. NCE's, Biopharmaceuticals and Cell and gene therapy approaches.

We are seeking experienced PKPD modellers ideally with expertise in quantitative pharmacology and/or drug metabolism and pharmacokinetic scientists with a track record of deploying PBPK and PKPD models to influence project direction and translational science. Successful candidates will be creative scientists, skilled at integrating data. A core function will be to characterise concentration-effect relationships from a variety of in vitro and in vivo data including pharmacodynamic effects in preclinical models and translate this to predict and guide outcomes in human clinical studies.

Critical to success will be your ability to integrate data using PBPK and PKPD to deliver the following essential evidence for each candidate

The understanding of drug kinetics at the desired site of action

Characterisation of drug dynamics against specific targets and pathways

Improved understanding of the connection between target engagement, surrogate biomarkers and potential clinical efficacy

Human dose prediction

Responsibilities

Develop and apply PBPK and PKPD models to influence critical decisions in drug discovery and development, including target selection, lead optimisation, candidate selection and early clinical development.

Develop and execute a modelling based strategy for preclinical projects, and lead the project team discussions on the human dose prediction prior to candidate selection.

Aid the interpretation of the data we generate, integrate it and in collaboration with, clinical and pre-clinical partners define project direction and decisions.

Use PBPK, PKPD modeling as a tool to help generate better hypotheses and design better, model-informed experiments.

Provide PKPD, Quantitative Pharmacology/DMPK scientific leadership and strategic input to enable rapid and efficient project progression across a portfolio of projects spanning early discovery interfacing with early clinical phases.

Establish strong relationships with Therapeutic Areas (TA), Drug Discovery, Pre-clinical and Clinical scientists across the GSK network as well as experts across the quantitative pharmacology/DMPK community both within GSK and externally.

As part of the Quantitative Pharmacology Community of Practice within GSK, define best practice, promote and increase the reputation and capability of modeling both internally within R&D and externally.

Through the use of a variety of software platforms develop and apply PBPK and PKPD models to influence critical decisions in drug discovery and development, including target selection, lead optimisation, candidate selection and early clinical development.

Establish concentration-effect relationships from preclinical experiments and provide translation modeling to predict human effects, human doses and early design of clinical trials.

Develop and execute a modelling based strategy for preclinical projects across therapy areas.

Work closely with other preclinical scientists and with matrix teams to aid the design of experiments and interpretation of the data generated to define project direction and decisions.

Use PBPK, PKPD modeling as a tool to help generate better hypotheses and design better, model-informed experiments.

Provide modeling and simulation strategic input to enable rapid and efficient project progression across a portfolio of projects spanning early discovery interfacing with early clinical phases.

Establish strong, collaborative relationships with Therapeutic Areas (TA), Drug Discovery, Pre-clinical and Clinical scientists across the GSK network as well as experts across the quantitative pharmacology/DMPK community both within GSK and externally.

As part of the Quantitative Pharmacology Community of Practice within GSK, define best practice, prioritize key programs and promote and increase the reputation and capability of modeling both internally within R&D and externally.

Closing date for applications is27/10/17.

Competitive salary + benefits

To apply please submit your CV.

Contact information:
You may apply for this position online by selecting the Apply now button.

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jobDetails

Desired profile

Basic qualifications:
PhD, MSc or Batchelors' degree in biochemistry, biology, biomedicine, chemistry, pharmaceutical sciences or a related Quantitative Pharmacology or DMPK discipline.

Deep experience of using mathematical models to integrate available data and applying these to answer practical questions that have a positive impact on programme direction (e.g. PBPK, PKPD).
Must possess a high level of drug discovery, ADMET/PK/PD expertise across a variety of delivery routes.

Demonstrated track record of innovation and successful delivery of contributions to projects, for example in lead optimisation phases, including candidate selection, and provision of clear translation strategies and/or into early clinical studies.

Demonstrated collaborative behaviours and the ability to operate successfully in a matrix environment, working across functions/disciplines.
Good working knowledge of software packages to enable PKPD and PBPK modelling e.g. WinNonLin/Phoenix, GastroPlus, R and Nonmem

Preferred qualifications:
Ability to work across a variety of therapeutic areas covering a range of modalities e.g. NCE's, Biopharmaceuticals and Cell and gene therapy approaches.

Evidence of identifying, developing, and applying innovative solutions to scientific and technological problems when delivering a quality preclinical PKPD package for molecule selection and progression.