Dear all,
GlaxoSmithKline (GSK) is hiring Clinical Pharmacologists (Sr. Scientist to Associate Director) in the Clinical Pharmacology Modelling and Simulation (CPMPS) group in China. As a member of our global CPMS department, you will have the opportunities to work as the clinical pharmacology lead for China or Asia development/registration projects. Below are the responsibilities and qualifications for the position. If you are interested in this position, please send your CV to [email protected]<mailto:[email protected]>. Thank you, Xuan Xuan Zhou Ph.D. Director of Clinical Pharmacology, Modelling & Simulation China R&D, GSK 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 justifying dose recommendations for Chinese population by using quantitative approaches * 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, physicians and regulatory affair staffs * 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 * 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, analyzing 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 * Knowledge of, or ability to quickly learn, the mechanism, endpoints, progression and treatments of relevant diseases * 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
