Senior Manager, Clinical Supply Chain

Supply Chain

Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million.

At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that serves them.
Our tenacious, passionate employees' challenge the status quo and work to develop unique therapeutics that have the potential to set new standards of care for people living with kidney disease.

This is life-changing work, and we are all in, are you?

Job Summary

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.

Essential Functions & Duties

• 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 crossfunctional 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

Basic Qualifications

• 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

Preferred Qualifications

• 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 problemsolving ability within regulated environments
• Effective collaborator in global, matrixed organizations

Travel Requirements

• Willingness to travel to various meetings or vendor sites, including overnight trips. Some international travel may be required

Compensation:

Targeted Base: *$163,306 - $201,731

*Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience, and may fall outside of the range shown. Base pay is only one component of the company's total rewards package, all regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.

Are you an Akebian?

An Akebian is curious, empathetic, and values making connections to people and ideas. Akebian's aren't afraid of diving in and owning a process or a problem, because we all want to deliver a great solution. Akebian's believe that we are better together because we are all working toward a common purpose - to better the life of each person impacted by kidney disease. Want to learn more about what it means to be an Akebian? Visit our website: www.akebia.com

Akebia is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristics protected by applicable law.