Principle Scientist, Omics Assay External Study Monitoring, Asia Translational Medicine

Company Overview: At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. Our R&D division is dedicated to discovering and delivering transformational vaccines and medicines that prevent and change the course of disease. We are leveraging cutting-edge science and technology to build a deeper understanding of patients, human biology, and disease mechanisms, transforming medical discovery. We are revolutionizing the way we conduct R&D by uniting science, technology, and talent to get ahead of disease together. Role Purpose: In this role you will provide technical oversight to enable the development, transfer, validation and delivery of omics assays (e.g., genomics, transcriptomics and proteomics ) in China to support clinical studies. Acting as a third-party monitor for external laboratories/CROs, you will ensure end-to-end assay and sample/data are executed with high quality, on time, and in a state of audit readiness. The role is heavily involved in China HGRAC activities and will also take on essential operational tasks to ensure compliant, efficient study delivery in China. This role offers a unique opportunity to influence biomarker testing strategies, contribute to translational and clinical research, and advance your career in a collaborative, high-impact environment. Key Responsibilities: Provide scientific expertise to implement omics assays in advanced genomics, transcriptomics and next-generation proteomics (NGP) technologies, including bulk RNA sequencing, single cell and single nucleus RNA sequencing, Olink PEA, Alamar-NULISA, Illumina protein Prep (Somalogic), qPCR, and dd-PCR, etc. Heavily engage in China HGRAC activities, ensuring appropriate review packages, tracking, responses and documentation are delivered on time and to quality. Ensure compliance with all GSK policies and procedures relating to Human Subject Research, Individual Human Data, and good data practices (FAIR, ALCOA). Provide expert input into clinical trial documents relevant to omics assays, such as Protocols, Informed Consent Forms, Lab Manuals, lab specifications, data transfer agreements and CRO Statements of Work. Act as third-party study monitor for China CRO/external laboratories performing omics assays, providing technical oversight, tracking progress against plans, and escalating risks/issues appropriately. Collaborating closely with Biomarker/Translational Leads, Biomarkers and Bioanalytical Platform teams, and cross-functional teams to align assay support with biomarker strategies and project requirements. Demonstrating strong project management skills by balancing multiple projects, meeting tight deadlines, and maintaining exceptional attention to detail and scientific rigor. Coordinate with Data Management/Biostatistics/biomarker & translational leads to align on omics data formats, transfer, QC, analysis readiness, and query resolution. Support CRO selection and oversight activities, including due diligence, technical qualification, KPI definition, invoice review/approvals (as applicable), and vendor performance tracking. Proactively identify challenges across the sample, assay, and data operations space impacting the delivery of Asia Translational Medicine strategy. Foster a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels, by role modeling the GSK values. Support other activities as required. Basic Qualifications: Master's Degree in relevant discipline (such as Biochemistry, Cell/Molecular Biology, Genetics, Genomics, Proteomics, or a related field). 5+ years of relevant work experience Experience with genomic and proteomic analytical platforms (e.g., NGS, qPCR, dd-PCR, Olink PEA, Alamar-NULISA, Illumina protein Prep [Somalogic]) is essential. Familiarity with China-specific governance processes such as HGRAC and proven experience coordinating review packages, responses and documentation. Demonstrated knowledge of the clinical development process, GxP, and global and China-specific regulatory requirements. Excellent communication skills, interpersonal skills, and matrix working skills. Self-motivated with the ability to work independently, as well as a highly motivated team player with a proactive attitude and ability to interact effectively within a multi-disciplinary team, including internal and external technical and business experts. Demonstrated attention to detail. Preferred Qualifications: Doctoral degree in relevant discipline Wet lab experience with Next Generation Sequencers (Illumina, ONT, PacBio) as well as in the design, troubleshooting, and implementation of NGS, qPCR, dd-PCR, Olink PEA, Alamar-NULISA, Illumina Protein Prep (Somalogic) applications, or comparable high-content methodologies is highly valued. Experience interpreting data generated by various methods and assays such as NGS, Olink PEA, Alamar-NULISA, Illumina Protein Prep (Somalogic) and other innovative genomics/proteomics techniques and commercial platforms is expected. Hands-on experience with automation platforms including Hamilton or equivalent systems, QiaCube, Mosquito, Dragonfly, F.A.S.T., and other automated liquid handling devices is added advantage. Experience supporting clinical studies in an assay/sample/data operational setting, including working with external laboratories/CROs and managing deliverables to timelines. Hands-on or oversight experience with omics assays and platforms (e.g., NGS-based genomics/transcriptomics, qPCR/ddPCR, proteomics platforms), including assay development, transfer and/or validation/verification concepts. Strong project management, stakeholder management and communication skills; ability to influence without authority and drive issue resolution with internal and external partners. High attention to detail, strong documentation practices and ability to manage multiple priorities in a fast-paced environment. Demonstrated experience with end-to-end omics assay delivery in clinical studies, including vendor oversight, method transfer packages, validation documentation, and data delivery/QC workflows. Experience managing high-dimensional biomarker datasets (e.g., NGS and proteomics), including data governance/privacy considerations and collaboration with bioinformatics/data science teams. Experience supporting audits/inspections (e.g., QA audits or Health Authority inspections) and driving CAPA/continuous improvement with external laboratories. Experience with LIMS and laboratory/sample tracking systems, and with creating operational metrics/KPIs for vendor performance management.