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.

Requirements

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.
Preferred Qualifications: Experience implementing LIMS or sample tracking systems.
Prior involvement in Phase 1–3 clinical programs.
Experience supporting regulatory inspections.

Benefits

A discretionary annual bonus may be available based on individual and Company performance

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

biosample managementsample logisticsbiomarker operationsGCPGCLPLIMSsample trackingclinical operationsdata reconciliationregulatory submissions

Soft skills

organizational skillscommunication skillscross-functional leadershipcoachingresource planningprofessional developmentstrategic oversightoperational oversightcontinuous improvementteam building

Certifications

Bachelor’s degreeadvanced degree in life sciencesGCP certificationGCLP certificationCLIA certificationCAP certification