Clinical Supply Chain Associate

Role Summary

The Clinical Supply Chain Associate will support drug supply activities related to planning, label development, label & pack, and distribution for one or more clinical programs. Actively develops and oversees supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste. Has a working knowledge of clinical supply best practices, IRT systems, as well as experience working within a cGMP environment.

Responsibilities

• Assist the Clinical Supply Chain Manager in supporting Clinical Study Teams (CST) and providing service to internal stakeholders (e.g., Clinical Operations, Regulatory, Quality, CMC).
• Help interpret clinical study protocols to understand supply needs and assist in aligning supply plans and timelines.
• Support the creation and maintenance of supply and inventory plans for clinical trial materials.
• Monitor production schedules and inventory under supervision, report discrepancies or issues to the Manager.
• Assist in managing GMP inventory, preparing inventory reports, and tracking drug accountability.
• Support relationships and daily activities with label & pack CMOs and distribution vendors as directed.
• Help investigate exceptions and support implementation of corrective actions under guidance.
• Assist in ensuring label text and proofs meet applicable rules, regulations, and study protocols.
• Coordinate review and approval of labels with stakeholders and CMOs as assigned.
• Support IRT user acceptance testing and ongoing supply activities in the system.
• Help coordinate and track shipments to CMOs, depots, and vendors; assist with import license tracking.
• Contribute to supply strategies to maximize efficiency and minimize waste, under supervision.
• Participate in cross-functional projects and process improvements related to drug supply as assigned.
• Assist in the creation of Standard Operating Procedures.
• Support change controls for Clinical Supply Chain as directed.
• Work with Regulatory to provide documentation for IND or other regulatory submissions as needed.
• All other duties as assigned.

Qualifications

• BS degree in life science or technical discipline. A degree in Supply Chain Management or certification is preferred.
• At least 3+ years experience in Clinical Supply Chain preferably within the biotech, pharmaceutical, CRO industry.
• Familiarity with clinical trials and supply chain processes is required.
• Basic understanding of global regulations for investigational medicinal products is a plus.
• Experience or coursework related to logistics, inventory management, or pharmaceutical materials is desirable.
• Strong management and organizational skills and detail orientation with an ability to prioritize, enable, and accelerate multiple programs and projects while simultaneously delivering against the activities of daily operations.
• Ability to thrive in a multidisciplinary team environment and build relationships.
• Proven agility and success in a dynamic company where change is frequent and rapid understanding and alignment is paramount.
• Computer skills including Microsoft Office Suite and working knowledge of IRT software.
• Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials.
• Excellent project management and communication skills, with emphasis on negotiating and problem solving.

Skills

• Project management
• Relationship building
• Regulatory documentation coordination
• Inventory management and logistics
• IRT system familiarity
• cGMP/GCP/GDP knowledge
• Proactive problem solving and communication

Education

• BS degree in life science or technical discipline. A degree in Supply Chain Management or certification is preferred.