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The Associate Director, Global Supply Chain reports to the Senior Director, Global Supply Chain and possesses a working understanding of clinical supply management and project management practices. The Associate Director, Global Supply Chain will support the Senior Director, Global Supply chain to ensure uninterrupted supply of Investigational Medicinal Product (IMP) for clinical studies as well as inventory of comparator drug products (if applicable).
Job Responsibility:
Assist with investigational drug product supply and logistics activities, including, but not limited to, demand forecasting and supply planning, IRT start-up and maintenance, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, returns, reconciliation, destruction, cold chain management, and inventory management
Maintaining oversight in monitoring inventory levels throughout the life of a clinical trial
Support with oversight of packaging and labeling/distribution vendors, including relationship management
Coordinate the preparation of clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinating the origination, proofing, and translation of clinical study labels and generation
Proactively identify potential issues, notify supervisor in a timely manner, and develop mitigating actions
Interpret clinical synopses and protocols to create clinical IMP demand forecasts
Attend clinical study and cross functional meetings as needed
Assist the global supply chain lead in overseeing the execution of multiple clinical trials and proactively identify potential supply chain issues and recommending solutions to global supply chain lead
Lead clinical study close-out activities, including returned goods reconciliation and inventory destruction
Assist with drug supply delivery through coordination of CMC efforts (including, but not limited to, CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)
Coordinate temperature excursion processes are executed as required
Support the IRT System Leads as necessary with regards to user requirement specifications and management module(s) as applicable
Lead organization and filing of documents on SharePoint sites
Requirements:
Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience or advanced degree with 5+ years of experience
6+ years of experience in clinical supply management
Knowledgeable in the implementation and workings of IRT systems
Ability to create a collaborative environment and manage multiple project activities
Strong computer skills including MS Office
Hands-on, roll-up-your-sleeves, collaborative approach with high sense of urgency and drive for results
Ability to think outside of the box and challenge the status quo
Desire to work in a fast-paced, innovative environment
Ability to travel up to 20%
Nice to have:
Experience with pharmaceutical development and manufacturing operations for development-stage clinical products