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
• Advanced training with a degr• 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
• Experience in designing, analyzing and reporting clinical studies, with a simulation- or modelling-based approach where appropriate
• Ability to communicate clearly and succinctly with the audience in mind, both orally and in writing
• Sound judgement, analytical mindset and problem-solving skills
• Ability to effectively multi-task and deliver results on time
• 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
• Familiarity with regulatory submission documents such as CTAs, INDs, NDAs, MAAs and BLAs
• Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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