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The department of Clinical Pharmacology Modelling and Simulation (CPMS) at GlaxoSmithKline is recruiting a Quantitative Clinical Pharmacologist at the Director level. CPMS is a science driven group delivering clinical pharmacology and modelling & simulation excellence to development programs. A successful candidate will have the opportunity to work on both small molecules and biologics in the immuno-inflammation area although there may be opportunities in the future to contribute to programs in other therapy areas. Position can be based at GSK UK or US sites, with a preference for the Stevenage, UK site.
• Contribute, as a member of a multi-disciplinary team, to the design of an efficient clinical development programs and robust registration packages
• Play a central role in predicting human dose range, characterising dose-response relationship and justifying dose recommendations for special populations
• Develop mathematical models to understand a 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 performance
• Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics
• Identify opportunities to utilize in silico PBPK approaches to replace in vivo clinical studies to explore the impact of DDI and special populations on PK where appropriate
• Write sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packages
• Present and defend quantitative clinical pharmacology plans and results through interaction and negotiation with internal governance committees and external regulators
• Innovate through working effectively with colleagues in the department and other matrix team members, including: statisticians, biologists, physicians and drug metabolism scientists
• Learn 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
• Promote model-informed drug discovery & development (MID3) strategies and approaches by publishing in peer-reviewed journals and presenting at scientific conferences
• Advanced training with a degree such as PhD, PharmD and MD to enable a successful career in quantitative clinical pharmacology in pharmaceutical research and development
• Substantial experience in clinical pharmacokinetics, modelling & simulation and drug development
• Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of diseases in oncology and other relevant therapy areas
• Understanding of pharmacokinetic and pharmacodynamic principles and commonly applied models; working knowledge of common tools for quantitative clinical pharmacology such as NONMEM, R, WINNONLIN, Simcyp, SAS and MATLAB
• Experience in designing, analysing and reporting clinical studies, with a simulation- or modelling-based approach where appropriate
• Familiarity with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs
• Understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical development plans and studies
• Ability to communicate clearly and succinctly with the audience in mind, both orally and in writing
• Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results
• Sound judgement, analytical mindset and problem-solving skills
• Ability to effectively multi-task and deliver results on time
• Demonstrated expertise in a specific technical area, and/or specific therapy area is preferred.
• Preferred requirement is demonstrated experience in drug development of novel oncology therapeutics
At GSK we are a science-led global healthcare company. We research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. Our mission is inspiring and challenging – to help people do more, feel better and live longer.
We have a significant global presence with commercial operations in more than 150 countries, a network of 86 manufacturing sites in 36 countries and large R&D centers in the UK, USA, Spain, Belgium and China.
WHAT DO WE OFFER?
At GSK we are all inspired by the difference we make and challenge ourselves every day to improve the lives of patients and consumers. That’s why we have created an environment where everyone feels valued, able to develop, contribute to our mission and be proud of what we achieve.
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