• 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.
• Sound understanding of pharmacokinetic and pharmacodynamic principles and commonly applied models
• Knowledge of, or ability to quickly learn, the mechanism, endpoints, progression and treatments of relevant diseases
• Working knowledge of common tools for quantitative clinical pharmacology such as NONMEM, Monolix, SAS, R and MATLAB
• Experience in using pharmacokinetic and pharmacodynamic modelling to design trials or to analyse results
• Ability to communicate clearly and succinctly with the audience in mind, both orally and in writing
• Ability to form effective collaboration while taking personal accountability for timely delivery of quantitative clinical pharmacology results
• Sound judgement, analytical mindset and problem-solving skills
• Ability to effectively multi-task and deliver results on time
• Experience in designing clinical pharmacology plans with a model-based mindset
• Experience in designing, analysing and reporting clinical studies with a model-based approach
• Familiarity with regulatory submission documents such as CTAs, INDs, NDAs/BLAs and MAAs
• Contribute, as a member of a multi-discipline team, to the design of an efficient clinical development program and a robust registration package
• Develop mathematical and statistical models to understand the disease, its progression and drug kinetics and dynamics
• Use models to integrate multi-source data to maximise the understanding of a disease and its treatments
• Conduct pharmacokinetic and pharmacodynamic modelling and simulation to aid informative design and interpretation of clinical studies
• Play a central role in predicting human dose range, analysing dose-response relationship and justifying dose recommendation for special populations
• Innovate through working effectively with colleagues in the department as well as others such as statisticians, physicians and drug metabolism scientists
• Present and defend quantitative clinical pharmacology plans and results through interaction with internal governance committees and external regulators
• Write sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packages
• Learn and apply emerging modelling and simulation methodologies with a view to enhance clinical trial efficiency and investment decision quality
• Collaborate with external field-leading teams of methodology development and application
• Promote model-informed drug development approach by publishing in peer-reviewed journals and presenting at scientific conferences
You may apply for this position online by selecting the Apply now button.
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