Senior Director, Biosample Operations

All Jobs >
Senior Director, Biosample Operations

Fully Remote
• Remote
• Biometrics, Clinical Operations, and Translational

Location: Remote

Department: Biometrics, Clinical Operations and Translational Science

Reports to: VP of Biometrics

The Senior Director of Biosample Management will lead the strategic and operational oversight of all clinical and nonclinical biosample activities across the company’s development pipeline. This role is responsible for building and managing end-to-end sample lifecycle processes—including collection, logistics, chain of custody, tracking, biobanking, vendor oversight, and data reconciliation. As a key cross‑functional leader within a small biotech organization, this individual will collaborate closely with Clinical Operations, Biometrics, Translational Research, Regulatory, Quality, and external partners to ensure sample integrity, compliance, and optimized scientific value.

Strategic Leadership & Governance

• 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.

Sample Lifecycle Oversight

• Lead the full lifecycle of  and translational samples: collection, processing, labeling, transportation, storage, analysis, and archival/disposal
• Ensure robust chain‑of‑custody and sample traceability systems.
• Design and maintain sample management plans, laboratory manuals, and related documentation.

Cross‑Functional & Scientific Collaboration

• 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.

Systems & Process Development

• 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.

Regulatory & Quality Oversight

• 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.

• Bachelor’s or advanced degree in life sciences or related field.
• 12+ years of relevant experience in biosample management, clinical operations, or translational/biomarker roles within biotech or pharma.
• 5+ years in a leadership or management role.
• Strong expertise in GCP/GCLP, sample logistics, biomarker operations, and lab oversight.
• Experience working in small or emerging biotechs with lean, hands‑on environments.
• Proven success managing complex sample‑intensive clinical programs (e.g., oncology, immunology).
• Excellent organizational, communication, and cross‑functional leadership skills.

• Experience implementing LIMS or sample tracking systems.
• Prior involvement in Phase 1–3 clinical programs.
• Experience supporting regulatory inspections.
• Strategic thinker with strong operational execution.
• Detail‑oriented with commitment to sample integrity and compliance.
• Collaborative leadership style suited for small company environments.
• Ability to manage ambiguity and build structure where none exists.
• Vendor and relationship management excellence.

The expected salary range for this position is: US, National: $230,000 - $290,000;…