Kelonia Therapeutics
Associate Director/Director, Clinical Bioanalytical Lab Operations
Be an Early Applicant
The role oversees global clinical bioanalytical lab operations for Phase I-III trials, focusing on biospecimen management, vendor oversight, and operational efficiency while ensuring compliance with regulatory standards.
Here at Kelonia Therapeutics, we aren’t just a clinical company; we’re trailblazers in viral engineering, pushing the boundaries of in vivo lentiviral gene and cell therapy. We're not just a team; we're dreamers on a mission to bring the promise of cell and gene therapy to every patient in need.
We've gathered a group of pioneers in cell and gene therapy to lead our journey, with extraordinary scientific founders at the helm, providing the cutting-edge technology that sets us apart. We're not just building a company; we're cultivating a culture that values both skill and care.
Are you ready to be a part of our remarkable journey? We're looking for someone exceptional to join our growing team as an Associate Director/Director, Clinical Bioanalytical Lab Operations in the Development group. This individual is responsible for the strategic leadership and operational oversight of global central laboratory across Phase I–III clinical trials. This role serves as the subject matter expert (SME) for biospecimen management, laboratory vendor oversight, and end-to-end sample logistics, ensuring GxP compliance, audit readiness, and high-quality execution.
Reporting to the VP, Clinical Development Operations, this individual partners cross-functionally with Clinical Development Operations, Bioanalytical Development, Clinical Development, QA, and Data Management to support development programs and efficient trial execution for central laboratory operations.
This isn't just a job; it's an opportunity to contribute to groundbreaking therapies, to be part of a company's inception, and to make a transformative impact on patients' lives. If you're passionate about scaling a company from the ground up, making a real difference, and shaping the inclusive culture we're proud of, this opportunity is tailor-made for you. Join us and be a driving force in achieving excellence in viral engineering.
What You will Do:
•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.
What You will Bring:
•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.
At Kelonia, we’re serious about balance and growth. You’ll get Flexible Time Off, flexible scheduling that aligns with your needs and our objectives, a competitive benefits package (health, commuter, and more), and great on-site perks that include free parking, a state-of-the-art gym, and a food hall – all within a collaborative, inclusive team that invests in your development and makes big things happen together.
Kelonia Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Kelonia does not accept unsolicited resumes from any source other than directly from candidates.
Top Skills
Ai-Enabled Tools
Sample Management Systems
Kelonia Therapeutics Boston, Massachusetts, USA Office
Boston, Massachusetts, United States
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