Associate Director, Bioanalytical Sciences

Role Overview

• Serve as the functional lead for Bioanalytical Sciences on cross-functional development teams.
• Develop and execute phase-appropriate bioanalytical strategies aligned with program objectives, timelines, and regulatory requirements.
• Provide strategic oversight of bioanalytical methods supporting PK, TK, biomarker, diagnostic, target engagement, pharmacodynamic, and immunogenicity analyses.
• Lead development, qualification, validation, transfer, and implementation of LBA and LC-MS/MS methods through external partners.
• Collaborate with Translational Sciences and Clinical Development teams to implement biomarker strategies supporting disease monitoring, patient stratification, target engagement, and pharmacodynamic assessment.
• Partner with Clinical Development, Clinical Operations, Biometrics, Data Management, and laboratory vendors to support protocol development, laboratory manuals, sample handling procedures, and bioanalytical operational plans.
• Oversee collection, processing, shipment, reconciliation, analysis, and reporting of bioanalytical samples across global clinical studies.
• Ensure timely transfer, review, reconciliation, and delivery of bioanalytical data to internal stakeholders, including Biometrics and Regulatory Affairs.
• Develop and maintain strategic relationships with CROs, central laboratories, and specialty testing laboratories.
• Monitor vendor performance and resolve scientific, operational, and quality-related issues.
• Support global regulatory submissions and ensure bioanalytical activities comply with applicable FDA, EMA, and other international regulatory requirements.
• Partner with Quality group on GCLP/GLP vendor audits and regulatory pre-approval inspections.
• Review bioanalytical reports and data packages to ensure scientific integrity, regulatory readiness, and data quality.

Requirements

• PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biology, Pharmacology, or a related scientific discipline
• Minimum 4 years of relevant experience in the biopharmaceutical industry
• Significant experience in regulated bioanalysis utilizing LBA and/or LC-MS/MS platforms supporting clinical and nonclinical development
• Demonstrated experience overseeing assay development, validation, and sample analysis through CRO partners
• Experience supporting global clinical studies involving multiple clinical sites, central laboratories, and bioanalytical testing laboratories
• Experience contributing to regulatory submissions and development documentation

Benefits

• premium health
• financial offerings
• work-life and well-being offerings for eligible employees and dependents
• wellness and employee support programs
• life insurance
• disability
• retirement plans with employer match
• generous paid time off