Lead global central laboratory operations across Phase I–III clinical trials, serving as the primary contact for specimen and sample management issues
Direct and oversee performance of central laboratories across clinical trials
Oversee end-to-end biospecimen tracking, reconciliation, and chain-of-custody processes to ensure data integrity and audit readiness
Direct and oversee clinical lab kit design, ordering, and inventory management
Direct external central, specialty, and imaging laboratory activities across multiple clinical programs, managing logistics for high-volume specimen processing
Design, implement, and continuously improve sample management systems and processes to enhance efficiency, reduce reconciliation errors, and streamline turnaround times
Leverage data analytics, automation, and emerging technologies (including AI-enabled tools where appropriate) to improve sample tracking, reconciliation accuracy, and turnaround time across global clinical trials
Ensure compliance with ICH-GCP, GxP, FDA inspection readiness requirements, and global biospecimen shipping regulations
Lead vendor qualification, selection, and due diligence activities for laboratory and imaging providers
Negotiate, initiate, and manage laboratory service agreements, Data Transfer Agreements (DTAs), and related contracts
Partner with QA to support vendor qualification audits and regulatory inspections
Monitor vendor performance through KPIs and proactively resolve laboratory-related issues, driving corrective and preventive actions (CAPAs) as needed
Collaborate with Clinical Development colleagues to integrate and operationalize bioanalytical testing strategies into clinical protocols and support patient identification and enrollment
Partner with Regulatory Affairs to ensure laboratory strategies align with protocol requirements and regulatory expectations
Coordinate sample-related data transfers and internal data exchange between testing laboratories, CROs, and Data Management teams
Develop and maintain laboratory and imaging manuals; provide guidance and training to study coordinators and investigators as appropriate
Define lab-related project timelines, mitigate risks, and ensure on-time, on-budget execution of sample and data deliverables
Represent the company in laboratory partner meetings and maintain strong, collaborative relationships with external vendors and stakeholders
Contribute to strategic planning, forecasting, and operational KPI development aligned with corporate goals

Requirements

Bachelor’s degree in Life Sciences or related field required; advanced degree preferred
10+ years of experience in clinical trial laboratory operations within biotech or pharmaceutical environments
Demonstrated experience supporting Phase I–III global oncology clinical trials
Strong knowledge of GxP, ICH-GCP, FDA inspection readiness, and global biospecimen shipping regulations
Proven track record in vendor selection, contract negotiation, and lab oversight
Experience with cell and gene therapy trials highly preferred
Exceptional cross-functional collaboration, leadership, and problem-solving skills
Ability to operate strategically while remaining hands-on in a fast-paced, growing organization

Benefits

Flexible Time Off
flexible scheduling that aligns with your needs and our objectives
a competitive benefits package (health, commuter, and more)
great on-site perks that include free parking, a state-of-the-art gym, and a food hall
a collaborative, inclusive team that invests in your development and makes big things happen together

Applicant Tracking System Keywords

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

Hard Skills & Tools

sample managementbiospecimen trackingdata analyticsautomationclinical lab kit designinventory managementvendor qualificationcontract negotiationproject managementKPI development

Soft Skills

cross-functional collaborationleadershipproblem-solvingstrategic thinkingcommunicationrelationship managementtrainingguidancerisk mitigationperformance monitoring