Deliver clinical biomarker and lead CDx activities in early and late oncology clinical studies to achieve milestones/goals aligned within R&D• China biomarker strategy alignment with global team, include but not limited to the biomarker testing plan, CDx strategies, assay format, vendor information, sample disposition plan, biomarker part of filing strategy etc.• As a biomarker SME in the clinical study team, lead coordinated efforts with necessary stakeholders to support operational execution of TA/project objectives and functional deliverables• Biomarker scientific contribution in all planned BLA submission and approvals, include but not limited to CSR, CO, BB, CDE consultation meeting, investigator meeting etc.• Successfully supported 6 sBLA filings with 2 approvals, 3 study inspections and many CTA approvals. • Lead the CDx development activities (three CDx devices) in China clinical studies, include but not limited to China CDx strategy discussion with global team and CDx partner, timely alignment on the timeline and Dx activities as well as risk management etc.• Biomarker and CDx guideline input, assessment and interaction with HA• Asset evaluation (internal early assets and external BD assets) from translational medicine perspective (most were oncology products, and there were several neuroscience and cardiovascular products).• Two-time consecutive top-performer in the team.• Communicate consistent messages with global counterpart function on project plans, activities, deliverables and decisions • Support HGRAC submission, include but not limited to review the HGRAC application documents, lead the discussion on HGRAC issues with key stakeholders etc.• Biomarker knowledge sharing with the clinical study team.

• Provide biomarker support for early and late oncology clinical studies, including delivering clinical biomarker strategy, supporting clinical development plan (indication selection, drug combination selection etc) and document preparation (protocol, ICF, lab manual etc), sBLA filing, central lab evaluation, biomarker assay setup, validation, execution and monitoring et al.• Clinical biomarker assay data analysis, interpretation and presentation to senior management team. • Support RP2D determination from pharmacodynamic biomarker perspective (e.g. receptor occupancy, soluble proteins etc) in phase 1 trials. Implement companion diagnostic development strategies in pivotal or phase 3 trials through integration of functional stakeholder input. Lead internal and external cross-functional teams required to manage and execute external diagnostic development partnerships with third parties from inception through regulatory approval in multiple jurisdictions.• Successfully support the RP2D determination with input of PD biomarkers in 1 ph1a study, indication selection with input of translational research in 1 ph1b study, and a biomarker driven ph3 study design. Successfully lead one CDx de-vice development in a pivotal study. • Actively participate in cross-function collaboration with clinical study team and translational research team to answer the scientific questions as regards drug targets, predictive biomarkers or other relevant biomarkers.• Biomarker operation support on budget making, contract preparation and sample management.

• Provide biomarker support for Ph1 and 2 oncology studies in China and Asia Pacific. Engage in protocol preparation, central lab evaluation, molecular screening/diagnostic assay development/validation.• Clinical sample management and process monitoring.• Clinical biomarker assay data analysis. Communicate with clinical sites/central labs for problem-solving and data quality improvement.• Support translational research collaboration with hospitals/universities.• Biomarker operation support on budget making and contract preparation.

• Lead in vitro and in vivo studies to assess the phenotype, antitumor activity and safety profile of lead Car-T cell products (cell-based assays and xenograft models).o Functional test of Car-T products by cytokine release assay and ELISA.o Antigen expressing stable cell-line establishment using Lenti-virus and Facs sorting.o Car-T in vivo efficacy study by tumor bearing xenograft mouse models.o Car-T cells establishment using G-Rex closed system.• Collaborate with the product sciences group to characterize GMP-like Car-T cell products.• Maintain detailed records of experimental protocols and results for IND filing.• Train and mentor other scientists in the group as needed.

• Translational research on Familial hypercholesterolemia (FH) disease (collaborated with Fuwai Hospital).o FH Sample collection with Fuwai hospital staffs.o Whole exon genome sequencing using FH patient samples.o LDLR gene function assay development by Facs. LDLR surface expression test LDLR-LDL binding assay LDLR endocytosis testo ApoB gene function assay development Cell proliferation assay in U937 cells.o Assay transfer to Fuwai hospital staffs.• miRNA biomarker identification in atherosclerosis (AS) cell and mouse models and function MoA study.• Cardiovascular biomarker study support using ELISA and Luminex assays.