Associate Director/director, Clinical Bioanalytical Lab Operations

Kelonia Therapeutics Inc

Boston, MA, United States
On-site
Global central laboratory operations
Biospecimen management and logistics
Gxp and ich-gcp compliance
This individual is responsible for the strategic leadership and operational oversight of global central laboratory across Phase I–III clinical trials

Job Summary

  • This individual is responsible for the strategic leadership and operational oversight of global central laboratory across Phase I–III clinical trials.
  • Ensure compliance with ICH-GCP, GxP, FDA inspection readiness requirements, and global biospecimen shipping regulations.
  • 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.

Matching Summary

This individual is responsible for the strategic leadership and operational oversight of global central laboratory across Phase I–III clinical trials.

Skills & Requirements

Must-have

  • Global central laboratory operations
  • Biospecimen management and logistics
  • GxP and ICH-GCP compliance
  • Vendor qualification and oversight
  • Clinical trial sample management

Nice-to-have

  • Pioneers in cell and gene therapy
  • Inclusive team culture
  • Data analytics and automation

Key Requirements

  • Bachelor’s degree in Life Sciences or related field
  • 10+ years of experience in clinical trial laboratory operations
  • Experience supporting Phase I–III global oncology clinical trials
  • Experience with cell and gene therapy trials highly preferred

Work Rights

Not specified

Tailored Resume

Cover Letter