Director, Clinical Trial Materials

Role Summary

Director of Clinical Trial Materials supports planning and execution of CTM activities for Phase 1–IV and IIS trials. Responsibilities include goal setting for the CTM team, demand forecasting, budget management, production scheduling, protocol review, label development, and cross-functional alignment with regulatory requirements. The role interfaces with internal departments, CROs, and CMOs to ensure compliant production and distribution of investigational products, and mentors junior CTM staff.

Responsibilities

• Review and interpretation of a clinical protocol or study overview, 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 procedures
• Regularly review and update inventories and supply plans against clinical forecasts, including lot numbers, status, kit genealogy, and expiration date extension
• Track expired materials and issue orders for retrieval or disposal
• Be proficient with current inventory and tracking systems, learn usage, updates, and maintenance
• Challenge current processes and strategies; provide innovative solutions to complex issues and pursue opportunities for improvement
• Investigate and resolve inventory, shipment, and returns issues
• Oversee end-to-end CTM lifecycle to ensure timely and uninterrupted supply of CTM for all trials
• Provide and support budgets for existing and planned projects
• Support CTM activities with packagers, distributors, Technical Services, Clinical R&D, project teams, IT/IS, Data Management, CROs, and other sites as necessary
• 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, update SOPs, and manage projects as assigned

Qualifications

• Minimum Bachelor of Science in Health Science (Master’s preferred); equivalent combination with at least 10+ years of experience in pharmaceutical development focused on clinical trial materials
• Strong working knowledge of GMP, GCP, GDP and other regulatory requirements for investigational products
• Proven project management skills
• Ability to develop team capabilities and provide training to enhance operational effectiveness
• Ability to manage multiple projects and staff simultaneously
• Excellent understanding of GMP environments and regulatory guidance (e.g., ICH, 21 CFR Part 11)
• Strong knowledge of IRT system build-up and user testing
• Experience in negotiating with customers and suppliers
• Hands-on training in clinical trial methodology and Good Clinical Practice
• Excellent organizational and documentation skills
• Proven ability to self-direct and resolve issues with vendors, CRO staff, and internal teams
• Excellent written and verbal communication; ability to convey complex knowledge to all levels
• Ability to foster a cooperative team environment and objectively evaluate situations for project needs

Education

• Minimum Bachelor of Science degree in Health Science; Master’s degree preferred

Additional Requirements

• Regular standing, walking, sitting; use of hands for handling or operating equipment
• Ability to travel independently overnight and/or work after hours as required by travel schedules or business needs