Associate Director/Director, Clinical Bioanalytical Lab Operations

Role Overview

• 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

Tech Stack

• Google Cloud Platform

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