Clinical Bioanalysis (Associate) Manager/Senior Manager of Large Molecule/Small Molecule in DMPK-BA

The DMPK-BA Department of BeOne is seeking a highly motivated individual to handle the clinical bioanalysis studies in large molecules and small molecules. The successful candidate will have demonstrated experience with Immunogenicity and PK assay practices in support of biologics/chemical drugs clinical development, regulatory guidelines associated with these assays and experienced in interacting with regulators. Job description: Act as clinical bioanalysis project manager in charge of biologics or small molecules. Work closely with cross functions in BeOne to establish innovative development portfolio of new candidates. Manage timelines, budget, and logistics operations of the outsourced activities, ensure quality and GLP/GCP compliance. Maintain 100% compliance with all internal and external requirements. Single point of contact between BeOne clinical teams and bioanalytical labs (CROs). Maintain effective communication with outsourcing management and CROs. Identify and evaluate new CROs in China and ex-China based on project specificity. Act as subject matter expert for bioanalytical labs qualification. Provide technical instruction to the team. Support trouble shooting in bio-analytical assay transfer, method validation and sample analysis. Involved in any regulatory submission or inspection. Other duties as assigned. Requirements: A PhD or Master with at least 5 years of working experience in relevant scientific field Strong expertise in bioanalytical application of LC-MS/MS, ligand binding assays including immunogenicity assays is required. Previous experience in clinical trials management is a plus. Demonstrated understanding of the Good Laboratory Practices, Good Clinical Practices and worldwide regulatory guidance (including but not limited to NMPA, FDA, EMA and ICH, etc.) for bioanalytical method validation and immunogenicity assays is required. Ability to manage multiple projects to meet aggressive timelines and ability to collaborate within multidisciplinary teams is required. Good oral and written skills in English are required.