岗位描述
Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D
Position Summary
We are seeking a highly motivated and experienced quantitative clinical pharmacologist to join our team supporting the Clinical Pharmacology Modelling and Simulation (CPMS) activities within Asia Translational Medicine, where quantitative modeling, clinical pharmacology, biomarkers, and translational data science are integrated to enable model-informed research and development. This role focuses on delivering CPMS strategy and quantitative excellence to research and development programs in Asia, helping to inform and accelerate the advancement of innovative therapies by ensuring they reach the right patients, at the right dose, and at the right time.
This role offers a unique opportunity to shape global clinical development by leveraging Asia's rapidly evolving biomedical innovation ecosystem, diverse patient populations, and growing translational research capabilities to generate actionable insights with enterprise-wide impact. Principal accountabilities for the role will be focused on strategy and delivery of project impact in Asia, but you will partner closely with local, regional, and global colleagues across R&D from CPMS, Translational Medicine, Clinical Development, and Regulatory Affairs to design and deliver strategic and scientifically robust clinical pharmacology plans aligned with global research & development strategies.
Working arrangement
This role is based in Shanghai, China and will be a hybrid role. You will typically be expected on-site 2 to 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:
Defining and executing clinical pharmacology and model-based development strategies across GSK portfolio for Asia regions
Planning, conducting and reporting of population PK and exposure-response analyses, simulation-based trial design and dose selection
Partner and collaborate within cross-functional teams including biology, translational and clinical to define, prioritize and deliver clinical pharmacology insights to impact pipeline progression.
Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies
Contributing to clinical program design, study protocols, analysis plans, study reports and regulatory submissions
Writing or reviewing clinical pharmacology components of regulatory documents and responses such that GSK products are rapidly and efficiently approved in Asia with optimum labelling (with regards to the clinical pharmacology, modelling and simulation contents)
Implementing best practices, trends, lessons learned from internal and external sources to further clinical pharmacology modelling and simulation contributions to R&D pipeline
Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation
Why You?
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
PhD, PharmD, MD, or equivalent doctoral degree in Pharmaceutical Sciences, Quantitative and/or Clinical Pharmacology, Bioengineering, Mathematics, Medicine, or a related quantitative discipline.
5+ years of experience in the design, analysis, interpretation and reporting of Clinical Pharmacology studies per industry and regulatory standards
5+ years of utilizing and leveraging population PK and exposure-response modelling in drug development; and verifiable proficiency in pharmacometric tools (e.g., NONMEM or R).
Preferred Qualification
If you have the following characteristics, it would be a plus:
Knowledge of or ability to quickly learn disease biology, mechanisms, trial design, endpoints and treatment paradigms in assigned disease areas
Solid experience with advanced pharmacometric approaches such as mechanistic PKPD modelling, longitudinal disease modeling, model-based meta-analysis, or adaptive dosing simulations
Demonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results
Clear evidence of ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks
Passion for quantitative clinical pharmacology and desire to innovate for better outcome
Experience working with senior stakeholders in a cross functional environment
Excellent interpersonal skills with strong oral/written communication and presentation skills
Strong track record of implementation of Model-Informed Drug Discovery and Development (MIDD) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs