Job DescriptionHow You'll Contribute:The
Clinical Supply Specialist II is responsible for supporting the planning, coordination, and execution of clinical supply activities across assigned clinical programs. This role applies working knowledge of clinical supply chain processes to ensure investigational product is available to clinical sites in accordance with study timelines, regulatory requirements, and quality standards. The position contributes to forecasting, distribution planning, and vendor coordination while collaborating with internal stakeholders and external partners. The Clinical Supply Specialist II operates with moderate independence, solving a range of defined problems and supporting continuous improvement in supply chain processes.
What You'll Do:This role supports the execution of clinical supply strategies and operational activities for assigned studies, ensuring timely delivery and compliance with applicable standards. The position collaborates cross-functionally and contributes to effective supply planning and issue resolution.
- Support development and execution of clinical supply plans, including forecasting, distribution, and inventory management for assigned studies
- Coordinate investigational product shipments to clinical sites, ensuring compliance with regulatory, quality, and study requirements
- Collaborate with Clinical Operations, CMC, Manufacturing, Quality, and external vendors to ensure supply readiness and continuity
- Monitor inventory levels and study demand, identifying potential risks and escalating issues as needed
- Assist in packaging, labeling, and distribution activities, ensuring alignment with protocol requirements and regulatory standards (e.g., GCP, FDA)
- Maintain accurate supply documentation, tracking systems, and study records to ensure audit readiness
- Contribute to vendor coordination activities, including communication, performance tracking, and issue resolution
- Support implementation of supply chain processes, tools, and best practices to improve efficiency and reliability
- Participate in study team meetings to provide updates on supply status, risks, and mitigation plans
How You'll Get There:- Typically requires 2-5 years of experience in clinical supply chain, clinical operations or related field
- Experience supporting clinical trials or regulated environments, including investigational product handling and distribution
- Working knowledge of clinical supply processes, including forecasting, inventory tracking, and logistics coordination
- Ability to analyze data and resolve moderately complex issues using established procedures and practices
- Experience collaborating across functions and building effective working relationships with internal and external stakeholders
- Strong organizational, communication, and project coordination skills
- Experience with clinical supply systems (e.g., IRT or inventory systems) preferred
- Bachelor's degree required (biological sciences, health sciences, supply chain, engineering, business, or related discipline).
- 81,000.00 - 101,200.00 Range plus full benefits package
- This role works onsite in our worldwide headquarters, Aliso Viejo, CA
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