Director, Clinical Trial Materials

Role Summary

Director, Clinical Trial Materials responsible for supporting the Sr. Director CTM in planning and execution across Phase 1-IV and IIS trials. Defines team goals, forecasts demand, manages budgets, sets production schedules, reviews protocols, ensures label development, aligns cross-functionally with regulations, and establishes packaging and distribution strategies. 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 clinical protocols or study overviews, provide feedback during protocol development
• Evaluate total demand and translate into demand forecasts
• Interface with Project Managers to develop clinical supply timelines, study overviews, drug requirements, and initiate procurement
• Regularly review and update inventories and supply plans against forecasts, including lot numbers, status, genealogy, and expiration considerations
• Track expired materials and issue orders for retrieval or disposal
• Maintain proficiency with inventory and tracking systems; learn usage, updates, and maintenance
• Challenge current processes and propose improvements; provide innovative solutions to complex issues
• Investigate and resolve inventory, shipment, and return issues
• Oversee end-to-end CTM lifecycle ensuring timely, uninterrupted clinical supplies
• Provide and support budgets for existing and planned projects
• Support CTM activities with suppliers, Technical Services, Clinical R&D, Project Teams, IT/IS, Data Management, CROs, and other sites
• Develop and maintain CTM documentation to support policies, procedures, and regulatory guidelines
• Collaborate with Clinical, Regulatory, and Quality teams on label text, translations, and proofs
• Collaborate with vendors to optimize relationships
• Prepare and review contracts, project statements, change orders, packaging requests, and batch records for accuracy
• Reconcile and approve invoices
• Prepare reports ensuring accuracy of clinical supplies information; maintain reports/files and update SOPs as assigned

Qualifications

• Minimum Bachelor of Science in Health Science (Master‚Äôs preferred); equivalent experience with 10+ years in pharmaceutical development focused on CTM
• Strong knowledge of GXPs (GMP, GCP, GDP) and regulatory requirements for investigational products
• Proven project management skills
• Experience building and training teams; ability to manage multiple projects
• Understanding of GMP, ICH, and 21 CFR Part 11 regulations
• Knowledge of IRT system build-up and user testing
• Negotiation skills with customers and suppliers
• Hands-on experience in clinical trial methodology and GCP
• Excellent organizational and documentation skills; strong written and verbal communication
• Ability to convey complex knowledge to diverse audiences and foster a cooperative team environment

Skills

• Inventory management and demand forecasting
• Protocol review and clinical supply planning
• Vendor and contract management
• Budgeting and cost control
• Regulatory compliance and quality systems
• Cross-functional collaboration and stakeholder management

Education

• Bachelor of Science in Health Science or related field; Master‚Äôs preferred

Additional Requirements

• Travel as required by project needs
• Regular standing/walking and ability to lift up to 20 pounds; willingness to work after hours as needed