The Associate Director, Biosample Operations Management (AD, BOM) is responsible for the planning and execution of biological sample collection (Biomarker/CDx, PK, PD, ADA), translational, and biomarker strategies for Zai’s rapidly growing pipeline of small and large molecules in early- through late-stage clinical development. This role establishes operational objectives, policies, procedures, and work plans. This leadership position requires an innovative thinker with strong problem-solving skills and the ability to work both independently and collaboratively. This role is based in our South San Francisco, CA office. Ensure the implementation and execution of the clinical biomarker and diagnostic plans for clinical programs in early- and late-stage clinical development across therapeutic areas.Define strategic timelines, allocate essential resources, and oversee budget management to support the biosample operations team effectively.Accountable for ensuring that data received is consistent with the collection and assay plans and protocol in conjunction with Translation Medicine and Data Management teams.Review the clinical study protocol and ICF for collection and analysis rationale, the feasibility of biological sampling, and alignment with Zai Lab policies and study/program plans.Utilize operational and project management skills to think through issues to ensure deliverables are met; supports the team in problem solving complex issues.Maintain oversight of all study biosample operational activities and regularly report on status across the portfolio of programs/studies.Monitor effectiveness of Investigator site sample handling training and quality of samples received and recommend corrective actions as necessary.Ensure study adherence to ICH/GCP and SOPs.Identifies areas of best practice and process improvements.Support the development of infrastructure to support the organization, including objectives, policies, procedures, and work plans. 
 
