Enliven Therapeutics

Operations

• 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.

Senior Director, Biosample Operations