Lab Head, Quantitative, Translational and ADME Science

Role Summary

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).

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.

Requirements

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.

Benefits

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.

• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
• https: //www.abbvie.com/join-us/reasonable-accommodations.html

About the Company

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.