Site Name: China - Shanghai - PuDong New District - Lane 999 Huanke Road - Building18, China - Beijing - ChaoYang District - Ocean International Centre - Tower A
Posted Date: Aug 6 2024
Position: Senior Scientist, Clinical Pharmacology Modelling & Simulation
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
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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