Dear all, We wish to announce a senior-level position (Sr. Scientist to Director) in the Clinical Pharmacology Modelling and Simulation (CPMS) group of GlaxoSmithKline (GSK) in Shanghai.
GSK provides a supportive environment for scientists who are aspired to learn, to contribute and to make impact on business decisions through innovation. The position level for a successful candidate will be based on the person's skills and experience. As a member of our global CPMS department, you have the opportunities to work as the clinical pharmacology lead for China and global development/registration projects. Below are the responsibilities and qualifications for the position. If interested, please send your CV to: peiming.p.ma_at_gsk.com<mailto:peiming.p.ma_at_gsk.com>. Sincerely, Peiming Ma 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, characterizing dose-response relationship and justifying dose recommendations for special population * Develop mathematical and statistical models to understand a disease, its progression, and pharmacodynamics and pharmacokinetics; conduct meta-analyses as appropriate to maximize 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, 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 * 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 GSK monitors email communications sent to and from GSK in order to protect GSK, our employees, customers, suppliers and business partners, from cyber threats and loss of GSK Information. GSK monitoring is conducted with appropriate confidentiality controls and in accordance with local laws and after appropriate consultation.
