The Laboratory Head, Quantitative, Translational and ADME Sciences, provides scientific, operational, and strategic leadership for a bioanalytical laboratory responsible for analyzing clinical trial patient samples and generating biomarker and immunophenotyping data to support pharmacodynamic assessments, patient stratification, and clinical decision-making throughout clinical development. The Laboratory Head is also accountable for establishing and maintaining a robust laboratory quality system to ensure reliable, inspection-ready data suitable for regulatory submissions. Operating within Development Sciences-China of AbbVie and working closely with cross-functional teams, this role drives the development and implementation of innovative bioanalytical capabilities while ensuring the timely delivery of high-quality data that support clinical development and accelerate clinical proof of concept (cPOC).
Key Responsibilities
- Build, mentor, and develop a high-performing laboratory team, fostering a culture of scientific rigor, operational excellence, continuous improvement, and collaboration.
- Manage the daily operations of the laboratory, ensuring efficient workflow, personnel safety, high-quality data generation, and timely delivery of clinical sample analyses.
- Supervise laboratory personnel, assign work, provide training and coaching, and ensure staff competency in laboratory procedures, instrumentation, and quality requirements.
- Provide scientific and technical leadership in biomarker and bioanalytical strategies, assay selection, technology evaluation, troubleshooting, and implementation of emerging analytical platforms.
- Establish, maintain, and continuously improve laboratory quality systems for the analysis of clinical trial samples and generation of data supporting global regulatory submissions.
- Ensure compliance with applicable regulatory requirements through robust laboratory practices, including development, enforcement and maintenance of laboratory policies, SOPs, personnel training and competency assessment, assay qualification and validation, equipment qualification and maintenance, sample chain of custody and traceability, documentation and record management, data integrity, deviation and CAPA management, and inspection readiness.
- Ensure robust assay performance, sample integrity, data quality, documentation, and timely reporting throughout the biomarker testing workflow.
- Oversee laboratory infrastructure, instrumentation, reagent inventory, vendor relationships, equipment qualification, maintenance, and laboratory safety.
- Partner closely with both China and global cross-functional teams, including Clinical Development, Precision Medicine and Companion Diagnostics, Discovery Research, Clinical Operations, Regulatory Affairs, and external collaborators, to align laboratory activities with clinical study objectives and regulatory milestones.
- Ensure laboratory activities are inspection-ready and conducted in accordance with applicable SOPs, quality systems, and regulatory expectations.