The department of Clinical Pharmacology Modelling and Simulation at GlaxoSmithKline is recruiting several quantitative clinical pharmacologists, at levels from Scientist to Senior Director. Successful candidates will have the opportunity to work on both small molecules and biologics in therapy areas including immunoinflammation, metabolic pathways, respiration, oncology, infection, neurosciences, dermatology, cardiovascular diseases and others. Positions are based in Stevenage and Uxbridge in the UK and in Upper Merion in the USA. Responsibilities may include:
* Contribute, as a member of a multi-discipline team, to the design of an efficient clinical development program and a robust registration package * Play a central role in predicting human dose range, characterising dose-response relationship and justifying dose recommendations for special populations * Develop mathematical and statistical models to understand a disease, its progression, and pharmacodynamics and pharmacokinetics; conduct meta-analyses as appropriate to maximise data use; conduct simulations to assess trial design performance * Design and interpret clinical pharmacology studies, including those to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics * 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 others such as 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 development approach by publishing in peer-reviewed journals and presenting at scientific conferences Basic and preferred qualifications are: * 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 * Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of relevant diseases * 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 * 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 GlaxoSmithKline provides a supportive environment for scientists who are aspired to learn, to contribute and to make impact on business decisions through innovation. We have several vacancies in our international department. The position level for a successful candidate will be based on the person's skills and experience. To apply, please visit our website (http://www.gsk.com/en-gb/careers/search-jobs-and-apply/) quoting req ID WD20837. Several members of our department will be attending this year's PAGE meeting 2nd - 6th June in Hersonissos, Greece. If you are also attending and would like to know more about these positions, please seek us out. We would be delighted to talk to you. Chao Chen, PhD Interim Global Head, Clinical Pharmacology Modelling & Simulation GlaxoSmithKline R&D chao.c.c...@gsk.com<mailto:chao.c.c...@gsk.com> ________________________________ This e-mail was sent by GlaxoSmithKline Services Unlimited (registered in England and Wales No. 1047315), which is a member of the GlaxoSmithKline group of companies. The registered address of GlaxoSmithKline Services Unlimited is 980 Great West Road, Brentford, Middlesex TW8 9GS.
