Senior Manager, Clinical Supply Chain

Akebia Therapeutics•Cambridge, MA

6h•$163,306 - $201,731

About The Position

The Sr Clinical Supply Manager is responsible for developing and executing global clinical supply strategies at the study level, ensuring timely and efficient delivery of investigational products to support clinical programs. This role oversees supply planning, inventory management, and distribution processes to maintain optimal stock levels at depots and clinical sites. The Sr Clinical Supply Manager collaborates cross-functionally to align supply operations with protocol requirements, proactively addressing risks and ensuring compliance with regulatory and quality standards. The ideal candidate is a detail-oriented problem solver with strong analytical, organizational, and communication skills, capable of managing multiple priorities in a fast-paced, dynamic environment.

Requirements

Bachelor’s degree (BA/BS)
7+ years of related experience within the pharmaceutical industry preferred
Knowledge of global R&D processes, quality principles, and cGMP/GLP/GCP regulations
Proficiency with IXRS, IRT, or other clinical trial management systems
Strong organizational, forecasting, and strategic planning skills; able to manage multiple projects independently
Experience managing CMO contracts, vendor relationships, and commercial drug development/product launch
Excellent interpersonal, written, and verbal communication skills for collaboration with internal teams, vendors, and regulatory authorities

Nice To Haves

Experience with packaging, labeling, global distribution, recalls, and regulatory requirements for clinical trial materials
Skilled in maintaining accurate, compliant records in accordance with GxPs
Proven creativity and problem‑solving ability within regulated environments
Effective collaborator in global, matrixed organizations

Responsibilities

Develop and execute clinical supply plans in alignment with study protocols and development timelines.
Collaborate with Clinical Trial Managers, CROs, and vendors to design and implement drug distribution strategies.
Coordinate packaging, labeling, and translations, ensuring compliance with regulatory and quality standards.
Oversee inventory management, forecasting, and reporting to maintain uninterrupted supply.
Track expiry dates and proactively address potential supply risks.
Oversee the procurement, distribution, and labeling of investigational product, comparator drugs, and ancillary trial materials.
Monitor site and depot inventory levels, shipments, and storage conditions.
Investigate and resolve temperature excursions to protect product integrity.
Facilitate cross‑functional meetings to align and fulfill clinical supply requirements.
Create and maintain SOPs, forms, templates, and work instructions for clinical supply processes.
Manage budgets, vendor performance, and timelines to meet project milestones.
Perform additional tasks as assigned to optimize clinical trial inventory, manufacturing, and logistics management