Associate Director – Clinical Supply Materials

Associate Director – Clinical Supply Materials

Requirements

• Bachelor of Science degree (BS) in Health Science (preferred Master of Science degree)
• At least 8 years’ experience in pharmaceutical development focused on clinical trial materials
• Good understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH, 21 CFR Part 11)
• Good understanding and working knowledge of IRT system build-up and user testing
• Hands on training and experience in clinical trial methodology and Good Clinical Practice
• Demonstrated track record of ability to self-direct and resolve issues with the vendors, CRO staff and internal teams
• Must be able to travel domestically and/or internationally on occasion if business requires.

Responsibilities

• Review and provide feedback during the development of the clinical protocol
• Calculate 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
• Proposes and implements improvements to assure efficient clinical supply operations
• 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
• Coordinates 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
• 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.

Preferred Qualifications

• Preferred Master of Science degree.