Lab Head, Quantitative, Translational and ADME Science

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.

Qualifications :

• Ph.D. in Immunology Cell Biology Molecular Biology Bioanalytical Sciences or a related scientific discipline with a minimum of 10 years of progressively responsible experience in bioanalytical translational or clinical biomarker laboratories. Experience analyzing clinical trial samples and generating data to support clinical development and regulatory submissions is required.
• Demonstrated leadership experience in establishing managing and developing high-performing laboratory teams and implementing laboratory quality systems that ensure regulatory-compliant inspection-ready operations.
• Proven expertise in biomarker and bioanalytical assay development qualification validation and implementation using multiplex ligand-binding assay platforms including Olink and/or Alamar Argo HT as well as high-throughput spectral flow cytometry platforms such as Cytek Aurora.
• Strong understanding of quality systems for laboratories supporting clinical development and regulatory submissions including laboratory documentation practices assay qualification and validation instrument qualification sample management and traceability data integrity (ALCOA principles) quality assurance deviation and CAPA management and inspection readiness. Experience operating within GCLP or comparable regulated laboratory environments is highly desirable.
• Demonstrated ability to lead cross-functional collaborations with Clinical Development Precision Medicine and Companion Diagnostics Clinical Operations Regulatory Affairs Quality external partners and global senior leadership to support clinical programs and regulatory milestones.
• Excellent leadership communication organizational and strategic planning skills with a proven ability to build scientific capabilities optimize laboratory operations and mentor multidisciplinary teams.
• Professional proficiency in both Chinese and English.

Additional Information :

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time