Director, Clinical Trial Materials

Role Summary

In support of clinical development programs, the Director of Clinical Trial Materials role supports the Sr. Director Clinical Trial Materials in planning and execution activities, supporting Phase 1–IV and IIS trials. Includes defining short and long term goals for the Team, demand forecasting and budget management, setting production schedules, protocol review, ensuring label development and working cross-functionally to align compliance with applicable regulations, establishing optimal packaging and distribution strategies, tracking and reconciling drug supplies and monitoring product re-test dates. Interfaces with internal departments and contract research organizations (CROs) and Contract Manufacturing Organizations (CMOs) as necessary to coordinate the execution of these activities. Implements and ensures group compliance to global applicable regulations and procedures for the production and distribution of investigation product. Mentors junior colleagues in the CTM team as required.

Responsibilities

• Review and interpretation of a clinical protocol or study overview, including providing feedback during protocol development and translating demand into a 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, current status, kit genealogy, and expiration date extension.
• Track expired materials and issue orders for retrieval or disposal.
• Proficient with current inventory and tracking systems, learn usage and maintenance, and challenge current processes to identify improvements.
• Investigate and resolve issues regarding inventory, shipments and returns; ensure end-to-end CTM lifecycle with timely, uninterrupted CTM supply.
• Provide and support budgets for existing and planned projects.
• Support CTM activities with CTM vendors and internal stakeholders (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; optimize vendor relationships.
• 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 and files and update SOPs as assigned.

Qualifications

• Minimum Bachelor of Science degree in Health Science (Master of Science preferred). Alternatively, a relevant combination of education and at least 10+ years of experience in pharmaceutical development focused on clinical trial materials.
• Strong knowledge of GXPs (GMP, GCP, GDP) and other regulatory requirements related to investigational products.
• Proven project management skills and ability to build and train 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).
• Excellent understanding and working knowledge of IRT system build-up and user testing.
• Experienced in negotiating with customers and suppliers; hands-on training and 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 at all levels.
• Demonstrated track record of self-direction and issue resolution with vendors, CRO staff, and internal teams; fosters a cooperative team environment.
• Able to objectively evaluate situations and make recommendations aligned with project demands.

Additional Requirements

• This role involves regular standing, walking, sitting, and use of hands for handling or operating equipment; travel required, including overnight trips.