Principal Scientist - ADME

About This Role

This role involves leading critical bioanalytical and drug-drug interaction (DDI) activities within Lilly's ADME discovery portfolio. The Principal Scientist will oversee external research partners, ensuring studies are delivered on time and on budget, while also applying AI and automation tools to enhance efficiency and data quality.

Responsibilities

• Lead bioanalytical and Drug-Drug Interaction (DDI) studies with external research partners, tracking progress in Smartsheet and resolving issues
• Manage study requests and vendor deliverables from intake through quality review
• Provide scientific oversight of CRO work, reviewing assay performance, data packages, deviations, and study reports to confirm results meet scientific and quality standards before acceptance
• Conduct annual scientific reviews of assigned vendors, escalate technical or data-quality concerns, and partner with scientists and quality teams to drive corrective action
• Ensure studies and contracts are delivered on time, within budget, and to scope: reconcile vendor invoices, confirm study completion before approval, and report on spend to stakeholders
• Partner with quality, finance, project leadership, and internal scientific teams to support vendor oversight and compliance
• Contribute to operational metrics, dashboards, and reporting to monitor performance and identify process improvements
• Apply approved AI and automation tools to streamline data review and reporting, with human review and in line with Lilly's data privacy and responsible AI policies
• Reconcile vendor commitments against actual utilization and support vendor governance, including performance reviews and contract renewals
• Build strong vendor relationships and share clear operational summaries and presentations with internal stakeholders

Requirements

• Bachelor's degree, preferably in a scientific field (e.g., chemistry, biochemistry, biology, pharmaceutical sciences)
• 7+ years of experience in a laboratory, CRO, or pharmaceutical operations setting, including vendor oversight
• Experience reviewing bioanalytical, DMPK, or DDI study data and reports, and communicating concerns to vendors and internal partners

Nice to have:

• Advanced degree in a scientific field
• Experience in ADME, bioanalysis, or drug metabolism and pharmacokinetics (DMPK), including in vitro and in vivo study types
• Familiarity with LC-MS bioanalytical platforms and software (e.g., Analyst, Watson) and CRO data delivery workflows
• Experience with CRO oversight and sponsor-vendor interactions, including budget and invoice management, performance monitoring, and process improvement
• Project management certification (i.e. PMP) and demonstrated ability to manage multiple concurrent projects/programs to meet deliverable timelines