• Lead the strategic and operational oversight of all clinical and nonclinical biosample activities across the company’s development pipeline. • Building and managing end-to-end sample lifecycle processes—including collection, logistics, chain of custody, tracking, biobanking, vendor oversight, and data reconciliation. • Develop and execute the company’s global biosample management strategy across all clinical programs. • Establish scalable sample governance frameworks suitable for a small but fast-growing biotech environment. • Serve as the subject-matter expert for biospecimen regulations, GCP/GCLP standards, and evolving global requirements. • Ensure robust chain-of-custody and sample traceability systems. • Design and maintain sample management plans, laboratory manuals, and related documentation. • Partner with Translational Medicine/Research to enable biomarker strategies, assay development, and laboratory readiness. • Work with Clinical Operations to incorporate sample needs into protocol design, site training, and monitoring. • Support Biometrics and Data Management in reconciling sample data with clinical datasets. • Identify, select, and manage CROs, central labs, specialty labs, and biorepositories. • Negotiate scopes of work and oversee budget, performance metrics, and quality compliance. • Implement and monitor KPIs, SLAs, and corrective action plans when needed. • Implement or optimize LIMS/sample-tracking systems appropriate for a small biotech. • Drive continuous improvement initiatives to streamline workflows and enhance sample, visibility. • Establish and maintain SOPs, work instructions, and forms related to biosample handling. • Ensure compliance with ICH/GCP, GCLP, CLIA, CAP, GDPR, and relevant global biospecimen regulations. • Support regulatory submissions (e.g., IND, CTA, BLA) with sample-related documentation. • Prepare for and support audits and inspections related to biospecimen management. • Build and lead a high-performing biosample management team as the company grows. • Provide coaching, resource planning, and professional development for direct reports.