锦鲤求职岗位描述
Position Summary
At GSK, we unite science, technology, and talent to get ahead of disease together. Our goal is to improve the lives of billions across the world. By bringing together outstanding people in an inclusive environment, we can make an impact on a global scale.
GSK is seeking an experienced clinical pharmacology scientist to join our team supporting the Clinical Pharmacology Modelling and Simulation (CPMS) department within Asia Translational Medicine. This role focuses on delivering CPMS quantitative excellence to development programs, helping to inform and accelerate the development of innovative oncology therapies by ensuring they reach the right patients, at the right dose, and at the right time. GSK provides a supportive environment for scientists who are aspiring to learn, to contribute and to make impact on business decisions through innovation, expertise, and influence.
As Associate Director, CPMS, you will be part of a science-driven group delivering clinical pharmacology and modelling & simulation excellence to research and development programs. You’ll have the opportunity to work on antibody drug conjugates, biologics and small molecules in the Oncology therapeutic area. CPMS responsibilities generally start post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to life cycle management.
Working arrangement
This role is based in Shanghai/Beijing, China and will be a hybrid role. You will typically be expected on-site 3 days per week, with flexibility according to business needs and local policy.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Ensure the optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and will have a proficiency in practice of Modeling & Simulation (M&S) and application of Model Informed Drug Discovery & Development (MID3) principles towards efficient drug development, risk management, and registration of compounds.
Develop and deliver Model Informed Drug Development Modelling and Simulation strategies to impact project strategy, decision making and accelerated approvals.
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 qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
PhD with minimum of 5 years’ experience 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 and Simcyp.
Evidence of CPMS strategy across programs and cross-functional leadership from clinical pharmacology perspectives within matrix development teams.
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 (Chinese and English); ability to provide own learnings, ideas, and experiences to internal stakeholders.
Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results.
Preferred Qualifications
If you have the following characteristics, it would be a plus:
· Experience supporting development programs in Oncology.
· Knowledge of, or ability to quickly learn, the mechanism, endpoints, progression and treatments of relevant diseases.
· Experience with AI/ML tools and applications in pharmacometrics.
· Experience in designing, analyzing and reporting clinical studies, with a simulation- or modelling-based approach where appropriate.
· Sound judgement, analytical mindset and problem-solving skills.
· Ability to effectively multi-task and deliver results on time.