Principal Scientist (Clinical Pharmacology)

Site Name: China - Beijing - ChaoYang District - Ocean International Centre - Tower A, China - Shanghai - PuDong New District - Lane 999 Huanke Road - Building18 Posted Date: Dec 4 2022 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 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. 致候选人的重要提示： GSK招聘团队只会使用 @gsk.com 后缀的邮箱与您联系。若您收到任何声称来自GSK邀请您面试或请您提供任何个人信息的邮件，我们建议您留意发件人的邮箱地址，并谨慎回复。若您不确定您所收到的邮件是否来自GSK，请您通过[email protected]联系我们。