Acts as CLS representative in the China Vaccine Matrix Team: Agree with Clinician and Regulatory stakeholders in the China Matrix Team on the core clinical laboratory assays to support the registration of GSK vaccines in China
Through close collaboration with the Senior Clinical Read-out Team Leaders in charge of the Project-related Clinical laboratory assays, ensure alignment with Global Vaccine R&D organization and Global Clinical Operations clinical read-out strategy. Closely interacts with the Global Clinical Operations representative at the Vaccine Matrix Team on operational aspects related to the selected clinical assays/laboratory strategy. Engage with the CLS stakeholders in China to optimize assay transfer and development plans and the delivery of laboratory results. Foster integrated end-to-end approach during implementation of the strategy. Escalate to the Project Senior Clinical Read-out Team Leader or the Head of Clinical Read-out Team Leaders major risks and issues that may impact the delivery of the strategy Actively work with Bioanalysis, Immunology and Biomarkers (BIB) China staff to build a strong lab assay matrix community and serve as the back up to the BIB China head as lab assay matrix community leader
Through regular interactions with the relevant stakeholders in GSK China, is aware and up to date on China regulations. Interacts appropriately with relevant Chinese bodies (academics, governmental agencies) within the respect of local rules as well as GSK rules, in order to implement the clinical laboratory strategy. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Master in Science, Vaccinology, Immunology 8 years in Clinical development/exposure to clinical trials with specific focus on clinical laboratory assays (functional assays ie viral neutralisation assays, bactericidal/opsonophagocytic assays, ligand-binding assays, T-cells assays, PCR) Excellent English/Mandarin verbal and written communication skills