Clinical Supply Lead | Shire | Lexington, MA, USA
Under the direction of the Head of Clinical Supply, the Clinical Supply Lead manages all aspects of providing clinical supplies including drug products (IMP), devices, and ancillary kits (as required) to support the protocol(s)/program the Lead is supporting. Activities include label text development, label specification review and approval, packaging and labeling operations, distribution, and drug product returns. The Lead will interact with both internal and external customers and suppliers in order to accomplish project objectives. The Lead will develop IMP distribution and return drug plans and manage Clinical Supplies documentation requirements. The Lead is responsible for monitoring inventory levels and providing feedback to the Clinical Project Manager regarding expiry and resupply. In addition, the Lead will participate or lead Clinical Supply group initiatives and continuous improvement activities.
Develops and implements clinical supplies strategy with Clinical and Medical project managers and contract provider. Monitors set-up with contractors, monitors progress, and when issues arise, work to implement corrective action to ensure timely delivery of clinical supplies to support trial requirements.
Creates label text in conjunction with Clinical Operations, Regulatory, and QA for all clinical supplies required. Manages the development, review, and approval of clinical label specifications.
Oversees packaging/labeling and distribution activities performed by CMO. Develops schedule to support requirements of the trial and is responsible for working with the CMO to deliver the clinical supplies compliantly and on time.
Works with internal and external customers to develop and implement IMP return drug management activities.
Assists in the development of IVRS supply and return strategy and participates in the User Acceptance Testing related to clinical supplies.
Manages clinical supplies inventory for projects assigned by interfacing with contractor to ensure that inventory systems are kept up to date and that final product reconciliation is completed.
Manages Clinical Supplies project files ensuring inclusion of essential documentation. Coordinates pre-audit/inspection review. Ensures appropriate documentation is uploaded to the TMF for projects assigned.
Leads or participates in global clinical supply or process improvement initiatives, developing rationale and creating implementation plans for change. Represents Clinical Supply for global R&D or other company process improvement initiatives.
EDUCATION AND EXPERIENCE REQUIREMENTS
BA/BS Degree: Business or Technical degree preferred or equivalent experience
7 years of Supply Chain experience (i.e. Global Logistics, Packaging and Labeling)
Experience with logistics and distribution with Third Parties within the pharmaceutical and/or biotech industry in cGMP and cGDP environment.
Experience with Cold Chain