Lead, Clinical Supply Chain Planning

Role Summary

Lead, Clinical Supply Chain Planning, reporting to the Sr. Director of Clinical Supply Chain. Primarily responsible for planning and scheduling clinical batches with manufacturing and CMOs to ensure continuous supply of radiopharmaceuticals for clinical programs, monitoring distribution to global clinical sites, and ensuring shipments comply with local rules and proper documentation. The role is remotely based within North America, preferably in the Eastern Time Zone.

Responsibilities

• Collaborate with clinical operations, CMOs, and the manufacturing team to ensure uninterrupted supply and timely delivery of clinical products throughout the clinical trial life cycle
• Maintain and support electronic files required for clinical supply (e.g., RAM licenses, site information database, shipping documentation)
• Schedule batches to maximize units per batch
• Evaluate, maintain, and track supply chain KPIs and contribute to continuous improvement of supply chain processes
• Develop and maintain good relationships with partners, CROs, CMOs, vendors, and suppliers
• Communicate and escalate supply chain risks to management with urgency and provide mitigation strategies
• Provide verbal and written reports to the manager in a clear, concise manner
• Maintain accurate and complete supply chain tracking logs (Excel)
• Adhere to all applicable procedures, cGLP, cGMPs, company policies, and quality/regulatory requirements
• Contribute to development and approval of supply chain procedures for clinical programs
• Promote a quality culture and “right-first time” approach in all activities
• Work effectively in a fast-paced team environment; perform other duties as assigned

Qualifications

• Required: Bachelor’s degree in Business, Supply Chain/Procurement, Engineering, Science or related field; or equivalent experience
• Required: 5+ years of supply chain and/or manufacturing scheduling experience
• Required: MS Excel experience with the ability to develop and manage complex workbooks
• Required: Availability to be on-call outside core business hours to support weekend deliveries (frequency based on production demand)
• Preferred: Early start time may be required to support EU clinical sites; experience with IWRS, IP ordering platforms; experience with MRP/ERP; experience with radiopharmaceuticals and Class 7 shipments; experience with CROs/CMOs/external vendors; FDA/regulatory environment knowledge (cGMP, GDP)
• Preferred: High attention to detail, strong organization, motivation, multitasking, and prioritization; excellent communication and interpersonal skills; solid project management capabilities
• Preferred: Ability to work independently and as part of a team

Skills

• Strong oral and written communication
• Interpersonal skills
• Planning and project management
• Ability to work in a fast-paced environment
• Attention to detail and organization

Education

• Bachelor’s degree in Business, Supply Chain/Procurement, Engineering, Science or related field; or equivalent experience

Additional Requirements

• Physical Demands/Travel: Minimal travel, a few times per year; office-environment physical requirements