Director, Clinical Trial Materials

Role Summary

Directs planning and execution of clinical trial materials in support of Phase 1–IV and IIS trials. Defines short- and long-term goals for the CTM team, forecasts demand, manages budgets, sets production schedules, reviews protocols, and oversees label development. Ensures regulatory compliance, establishes packaging and distribution strategies, tracks drug supplies, and monitors re-test dates. Coordinates with internal departments, CROs, and CMOs to execute activities and enforces global regulations for investigational products. Mentors 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 translation of total demand into a demand forecast.
  • Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement procedures.
  • Regularly reviews and updates inventories and supply plan against Clinical forecasts including all supply related information such as lot numbers, current status, and kit genealogy and expiration date extension.
  • Tracks expired materials and issues orders for retrieval or disposal.
  • Be proficient with current inventory and tracking systems by learning their usage, updates and maintenance.
  • Challenges current processes, practices and strategies
  • Provides innovative solutions to complex issues and consistently evaluates opportunities for improvement.
  • Investigates and resolves issues regarding inventory, shipments and returns.
  • Responsible for end to end, full CTM lifecycle, ensures that all clinical trials have timely and an un-interrupted supply of CTM.
  • Provides and supports budgets for existing and newly planned Projects.
• Supports CTM activities with Clinical Supply Packagers and Distributors, Technical Services, Clinical R&D staff, Project Teams, IT/IS, Data Management, CROs and other sites and departments as necessary
• Develops and maintains CTM documentation necessary to support company policies, procedures and all regulatory guidelines
• Works with Clinical, Regulatory and Quality teams in preparing label text, obtaining translations and approval of label proofs
• Works collaboratively with Vendors to optimize relationships and build confidence.
• Prepares and reviews applicable contracts, project statements, change orders, packaging requests, and batch records for accuracy and completeness
• Reconciles and approves invoices
• Prepares reports to ensure accuracy and completeness of clinical supplies information. Maintains departmental reports and files, updates SOPs and other projects as assigned

Qualifications

• The individual must be well versed in GXPs (GMP, GCP, and GDP) and as well as other regulatory requirements as they pertain to investigational products
• Proven project management skills
• Develops team building and training of staff to support Team skills and enhance operational effectiveness
• Ability to handle multiple projects/staff simultaneously
• Excellent understanding of GMP working environments and regulatory guidance and regulations (e.g., ICH, 21 CFR Part 11)
• Excellent understanding and working knowledge of IRT system build-up and user testing
• Experienced in negotiating skills with customers and suppliers
• Hands on training and experience in clinical trial methodology and Good Clinical Practice
• Excellent organizational and documentation skills
• Demonstrated track record of ability to self-direct and resolve issues with the vendors, CRO staff and internal teams
• Excellent written and verbal communication skills
• Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization
• Skilled at creating a cooperative team environment
• Able to objectively evaluate situations and make recommendations for changes in light of overall project demands

Education

• BS in Health Science; MS preferred. Equivalent combination of relevant education and applicable job experience may be considered with at least 10+ years of experience in pharmaceutical development focused on clinical trial materials.

Additional Requirements

• Physical requirements: This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to twenty pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.