Director, Clinical Trial Materials

Role Summary

In support of clinical development programs, the Director of Clinical Trial Materials (CTM) supports the Sr. Director CTM in planning and execution activities across Phase 1–IV and IIS trials. This role defines short and long-term goals for the team, manages demand forecasting and budgets, sets production schedules, reviews protocols, oversees label development, ensures regulatory compliance, and coordinates packaging, distribution strategies, and drug supply management. The role interfaces with internal departments, CROs, and CMOs, ensures group compliance with global regulations, and mentors junior CTM staff.

Responsibilities

• Review and interpretation of a clinical protocol or study overview
  • Review and provide feedback during the development of the clinical protocol.
  • 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 inventories and supply plans against forecasts, including lot numbers, current status, kit genealogy, and expiration date extensions.
  • Track expired materials and issue orders for retrieval or disposal.
  • Be proficient with current inventory and tracking systems.
  • Challenge current processes and strategies; provide innovative solutions; pursue continuous improvement.
  • Investigate and resolve issues regarding inventory, shipments, and returns.
  • Own end-to-end CTM lifecycle to ensure timely, uninterrupted CTM supply for all clinical trials.
  • Provide and support budgets for existing and planned projects.
• Support CTM activities with Clinical Supply Packagers and 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 and completeness
• Reconcile and approve invoices
• Prepare reports to ensure accuracy of clinical supplies information; maintain departmental reports and files; update SOPs as assigned

Qualifications

• Minimum Bachelor of Science in Health Science (Master‚Äôs preferred); or an equivalent combination of education and 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
• Experience building and training teams 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 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
• Proven ability to independently resolve issues with vendors, CRO staff, and internal teams
• Strong written and oral communication skills; ability to convey complex knowledge clearly
• Collaborative team player with ability to foster a cooperative environment
• Judgment to evaluate situations and recommend changes based on project demands

Education

• Bachelor of Science in Health Science (Master‚Äôs preferred)

Additional Requirements

• Physical requirements: Regular standing, walking, sitting, and use of hands; ability to reach, climb, balance, stoop, kneel, crouch; occasional lifting up to 20 pounds; travel overnight as needed