Director, Clinical Trial Materials

Role Summary

Director of Clinical Trial Materials provides leadership to plan and execute CTM activities in support of Phase 1–IV and IIS trials. Defines goals for the team, manages demand forecasting and budgets, sets production schedules, reviews protocols, ensures label development and regulatory compliance, establishes packaging and distribution strategies, and tracks drug supplies and re-test dates. Interfaces with internal departments, CROs, and CMOs to coordinate activities and mentors junior CTM team members.

Responsibilities

• Review and interpretation of a clinical protocol or study overview, providing feedback during protocol development
• Evaluate total demand and translate into a demand forecast
• Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement
• Regularly review and update inventories and supply plans against clinical forecasts, including lot numbers, current status, kit genealogy, and expiration date management
• Track expired materials and issue orders for retrieval or disposal
• Maintain proficiency with inventory and tracking systems and pursue process improvements
• Resolve issues related to inventory, shipments, and returns; ensure end-to-end CTM lifecycle with uninterrupted supply
• Provide and support budgets for existing and planned projects
• Support CTM activities with packagers, distributors, Technical Services, R&D, IT/Data Management, CROs, and other teams
• Develop and maintain CTM documentation to support policies, procedures, and regulatory guidelines
• Collaborate with Clinical, Regulatory, and Quality teams on label text, translations, and label proofs; optimize vendor relationships
• Prepare and review contracts, change orders, packaging requests, and batch records; reconcile invoices
• Prepare reports ensuring accuracy of clinical supplies information; maintain department files and update SOPs as needed

Qualifications

• Minimum Bachelor of Science in Health Science; Master of Science preferred. Equivalent experience with at least 10+ years in pharmaceutical development focused on clinical trial materials
• Strong knowledge of GXPs (GMP, GCP, GDP) and regulatory requirements for investigational products
• Proven project management skills
• Ability to lead, train, and develop a team; manage multiple projects concurrently
• Solid understanding of GMP environments and regulatory guidance (e.g., ICH, 21 CFR Part 11)
• Experience with IRT system build-up and user testing
• Negotiation experience with customers and suppliers
• Hands-on experience in clinical trial methodology and Good Clinical Practice
• Excellent organizational and documentation skills; strong written and verbal communication
• Ability to convey complex knowledge clearly across the organization and foster a cooperative team environment
• Ability to objectively evaluate situations and recommend changes based on project needs

Education

• BS in Health Science; MS preferred

Additional Requirements

• Physical requirements: regular standing, walking, sitting; use of hands for handling equipment; may require reaching, climbing, balancing, stooping, kneeling, crouching; occasional lifting up to 20 pounds; travel overnight as needed