Advisor, Bio Sample Operations, DMPK

About the role

End-to-end oversight of samples for safety testing, pharmacokinetics and biomarkers sits with this role, working alongside clinical operations, bioanalytical sciences, quality and regulatory teams plus outside vendors.

At a glance

What you will do

• Turn protocol and lab requirements into study-specific sample strategies, timelines, workflows and collection materials.
• Oversee the full sample lifecycle: collection, processing, labelling, shipment, storage, analysis, reconciliation and disposal.
• Manage central and specialty labs, biorepositories, couriers and CROs, including contracts, KPIs and SLAs.
• Handle operational and quality issues such as shipment problems, missing samples, deviations, CAPAs and audit findings.

What they look for

• Experience leading bio sample operations for clinical studies in a global setting.
• Knowledge of GCP regulations, SOPs and quality standards for clinical samples.
• Skill at managing outside vendors and laboratories against deliverables and service levels.
• Ability to keep sample traceability, chain of custody and inventory accuracy across systems.
• A track record of spotting operational risk and improving processes.