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The Director, Global Supply Chain reports to the Senior Director, Global Supply Chain and possesses a working understanding of clinical supply management and strategy, global regulatory requirements, and project management practices. The Director, Global Supply Chain partners with relevant internal functional groups to ensure uninterrupted supply of both Investigational Medicinal Product (IMP) for clinical studies as well as inventory of commercial drug products.
Job Responsibility:
Managing 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, cold chain management, and inventory management
Communicating supply strategies and supply needs to CMC stakeholders and providing input for developing manufacturing strategies to support those needs
Providing oversight in monitoring inventory levels throughout the life of a clinical trial or commercial product, including taking preventative actions to avoid potential supply issues
Providing day-to-day oversight of packaging and labeling/distribution vendors, including relationship management
Contributing to the preparation of clinical protocols, 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 management in a timely manner, and develop mitigating actions
Interpret clinical synopses and protocols to create clinical IMP demand forecasts
Oversee the execution of multiple clinical trials and proactively identify potential supply chain issues, including providing analysis and recommending solutions with appropriate support from SMEs
Support clinical study close-out activities, including returned goods reconciliation and inventory destruction
Manage and execute drug supply delivery through coordination of CMC efforts assigned to the entire project team (including, but not limited to, CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)
Ensure temperature excursion processes are executed as required
Guide the IRT System Leads as necessary with regards to user requirement specifications and management module(s) as applicable
Leverage inventory management capabilities of the IRT to appropriately manage clinical and commercial drug supply
Requirements:
Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience or an advanced degree with 8+ years
8+ years of experience in clinical supply management
Experience with global pharmaceutical development and manufacturing operations for development-stage and/or commercial products, including formulation development (pre-filled syringes, solid oral dosage forms, etc.), analytical development, and device development
Deep understanding of IRT systems
Ability to create a collaborative environment and manage multiple project activities with global contract CDMOs
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
Domestic or international travel is required (up to 20%)
Nice to have:
Experience with pharmaceutical development and manufacturing operations for development-stage clinical products