Director, Clinical Trial Materials

Role Summary

Director, Clinical Trial Materials. In support of clinical development programs, the Director of Clinical Trial Materials role supports the Sr. Director Clinical Trial Material (CTM) 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, ensures label development and works cross functionally to align compliance with applicable regulations, establishes optimal packaging & distribution strategies, tracks and reconciles drug supplies and monitors 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:
  • 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

• Minimum Bachelor of Science degree (BS) in Health Science (preferred Master of Science degree). 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
• 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

Skills

• Inventory management and forecasting
• Budget and resource planning
• Label development and translation coordination
• Vendor and CRO/CMO relationship management
• Regulatory compliance (GXP, GMP, GCP, GDP, ICH, 21 CFR Part 11)
• IRT system knowledge and user testing
• Contract management and invoicing
• Documentation, SOPs, and reporting

Education

• Minimum BS in Health Science; MS preferred

Additional Requirements

• Travel willingness to accommodate business needs