Associate Scientific Director, TB&B

Scientific leader with deep bioanalytical and biomarker expertise, accountable for building capabilities, shaping the strategic direction for bioanalytical and biomarker development and implementation, and ensuring timely, compliant delivery of PK, immunogenicity, and biomarker data for clinical trials in China. Serves as an expert across technologies (e.g., immunoassays, cell-based assays, flow cytometry, LC-MS/MS, genomics) and partners with TB&B and cross-functional stakeholders to advance clinical assets. Lead bioanalytical strategy and biomarker strategy for multiple programs in China; design and execute deliverables as the SME for bioanalysis, ensuring regulated bioanalysis meets global guidance and local requirements; provide scientific oversight of vendors for method development, validation, lifecycle management, and clinical sample testing; support data analysis and regulatory submissions (China submissions and interactions such as NMPA/CDE IND/NDA/BLA); draft responses to health authority questions; ensure alignment with study teams on compliant sample collection and data integrity; lead cross-functional TB&B matrix team to plan and execute deliverables; contribute to regulatory documents (protocols, IND/NDA submissions, briefing books, IB, CSR, IMPD/CCD, CTD); provide program updates to leadership; build cross-functional networks and represent TB&B in external forums; fluent in Chinese and English.