Role Summary
The Clinical Logistics Manager will oversee the end-to-end management of investigational product (IP) and non-IP clinical drug supply for Artivaโs AlloNK, off-the-shelf (allogeneic) cell therapy clinical programs. This individual will play a key role in ensuring timely and compliant delivery of clinical materials to global trial sites, managing logistics vendors, and maintaining robust site communication. The role requires close collaboration with Clinical Operations, Quality, CMC, Regulatory Affairs, Materials Management and external partners to support the successful execution of cell therapy clinical trials.
Responsibilities
- Manage the full lifecycle of investigational product (IP) and non-IP materials, including forecasting, labeling, packaging, distribution, and returns/reconciliation.
- Manage inventory of IP and non-IP materials both internally and externally.
- Ensure compliance with GxP, IATA, and country-specific regulations governing cell and gene therapy logistics.
- Oversee temperature-controlled shipments and chain-of-custody documentation to ensure product integrity.
- Partner with internal teams to establish supply plans aligned with clinical study timelines and enrollment projections.
- Serve as the primary logistics contact for clinical sites regarding product availability, shipment tracking, and issue resolution.
- Provide training and guidance to clinical sites on handling, storage, and return of IP/non-IP materials as needed.
- Maintain clear documentation of all site interactions and logistics communications.
- Manage relationships and performance of third-party logistics (3PL), packaging, and labeling vendors.
- Support vendor qualification, audits, and oversight in collaboration with Quality and Procurement as needed.
- Ensure service level agreements (SLAs), key performance indicators (KPIs), and quality standards are met.
- Work closely with Manufacturing teams and Materials Management to align supply chain activities with production schedules.
- Partner with Clinical Operations to ensure seamless coordination between supply logistics and trial execution.
- Support Regulatory Affairs in preparation of documentation for import/export licenses, IMPD updates, and regulatory submissions related to supply.
- Develop and implement process improvements for inventory management, forecasting, and site logistics coordination.
- Contribute to the design of digital tools or dashboards for real-time tracking of shipments and inventory.
Qualifications
- Required: Bachelorโs degree in Life Sciences, Supply Chain Management, Pharmacy, or related field.
- Required: 5+ years of experience in clinical supply chain, logistics, or clinical operations within the biotech or pharmaceutical industry.
- Required: Experience managing IP/non-IP logistics for advanced therapy medicinal products (ATMPs) or biologics.
- Required: Proven track record of vendor management and oversight of global supply chains.
- Required: Strong understanding of GxP, IATA, GDP, and cold-chain management principles.
- Required: Excellent project management and organizational skills.
- Required: Strong communication and stakeholder management abilities across cross-functional teams and clinical sites.
- Required: Detail-oriented with the ability to troubleshoot and resolve logistical challenges under tight timelines.
- Required: Experience with clinical supply management systems (IRT/RTSM, ERP, or equivalent).
- Preferred: Advanced degree in a related field.