Director, Clinical Trial Materials

Role Summary

Director, Clinical Trial Materials. In support of clinical development programs, the role supports planning and execution activities for Phase 1-IV and IIS trials, defining goals for the team, demand forecasting, budget management, production scheduling, protocol review, label development, and cross-functional alignment with regulations. Establishes packaging and distribution strategies, tracks drug supplies, and monitors re-test dates. Interfaces with internal departments, CROs, and CMOs to coordinate activities, ensures compliance with global regulations, and mentors junior CTM team members.

Responsibilities

• Review and interpretation of a clinical protocol or study overview:
  • Review and provide 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.
  • Track expired materials and issue orders for retrieval or disposal.
  • Utilize current inventory and tracking systems; learn usage, updates, and maintenance.
  • Challenge current processes and provide innovative solutions for improvement.
  • Investigate and resolve issues regarding inventory, shipments, and returns.
  • Own end-to-end CTM lifecycle to ensure timely and uninterrupted CTM supply.
  • Provide and support budgets for existing and planned projects.
• Support CTM activities with CTM staff and collaborators (Clinical Supply Packagers/Distributors, Technical Services, Clinical R&D, Project Teams, IT/IS, Data Management, CROs, sites, and departments).
• 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.
• Work with Vendors to optimize relationships and build confidence.
• Prepare and review contracts, project statements, change orders, packaging requests, and batch records for accuracy; reconcile and approve invoices.
• Prepare reports to ensure accuracy of clinical supplies information; maintain departmental reports/files and update SOPs as needed.

Qualifications

• Minimum Bachelor of Science in Health Science; Master‚Äôs preferred. Equivalent combination 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 and train staff; manage multiple projects simultaneously.
• Excellent understanding of GMP, ICH, and 21 CFR Part 11 regulations; strong IRT system knowledge.
• Experience in negotiating with customers and suppliers; hands-on clinical trial methodology and Good Clinical Practice.
• Strong organizational and documentation skills; ability to self-direct and resolve issues with vendors, CROs, and internal teams.
• Excellent written and verbal communication; ability to convey complex knowledge across organization levels; collaborative leadership.

Skills

• Inventory management and forecasting
• Contracting and procurement procedures
• Labeling, translations, and packaging operations
• Vendor and CRO/CMO relationship management
• Regulatory compliance awareness (GMP, GCP, GDP, ICH, 21 CFR Part 11)
• Project management and cross-functional collaboration
• Strong communication and problem-solving abilities

Education

• Bachelor of Science in Health Science; Master‚Äôs preferred

Additional Requirements

• Physical: Regular standing, walking, sitting; handling equipment; occasional lifting up to 20 pounds; travel overnight as required.