Associate Director, Clinical Supplies Project Manager

The Role

Associate Director, Clinical Supplies Project Management is responsible for oversight and leadership of clinical supply activities for a program and/or a clinical study. The scope includes the operational planning and strategy required to execute end-to-end supply management, including demand planning, label development, packaging/labeling, distribution, IRT UAT/supply management, temperature excursions, and site activations. This position works collaboratively across several therapeutic area teams and cross functionally to support study needs.

May be an individual contributor or lead a team of direct reports, including Clinical Supply Project Managers or Specialists. The role requires skill at understanding the needs of critical programs with attention to detail, with a collaborative outlook, and with the ability to manage workload and meet project timelines.

• Assists in identifying resources required to manage programs and their associated clinical studies.
• Provides leadership to more junior colleagues by supporting their development through coaching and identifying key opportunities for development.
• Accountable for planning, strategies and budget management for programs
• Drives best practice for supply logistics and for the processes surrounding clinical supplies
• Oversee process for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight and scope review related to clinical supplies
• Responsible for logistics as required to support the labeling, packaging and shipment of clinical drug supplies to depots/investigative sites as well as other clinical supplies as necessary
• May contribute to business review meetings with third party drug supply vendors
• With Clinical Study Team inputs and IRT PM, responsible to contribute to the development of IRT requirements, user acceptance testing, and supply management after IRT go‑live.
• Responsible for Clinical Supplies Planning and Forecasting as required to meet program objectives
• Develop and compile KPI (metrics)
• Primary interface with CMC for Production Planning & Distribution; develops best practice for forecast of all drug supply needs
• Manages work with Clinical Packaging Organizations, IRT vendors, and CROs
• Drives the creation/develop of processes that drive best practice for clinical supplies. Implements industry best practices for clinical drug supply activities
• Collaborates with CMC, clinical, and project management on production schedules so timing of clinical trial drug needs are met
• Maintains collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirements
• Responsible for coordinating and scheduling drug labeling and packaging activities in conjunction with CMC, clinical, regulatory departments; and coordinating the work schedule of clinical supplies project managers
• Oversee vendor activities including procurement, labeling performance, on-time delivery, quality, improvement initiatives and issue resolution
• Develop pharmacy manuals in conjunction with relevant cross functional leads
• Develop drug and clinical supply training materials for investigational sites

• At least 8 years of clinical supply management experience in a clinical research environment
• Bachelor’s degree in a science-based subject (advanced degree preferred)
• Prior Cold Chain distribution experience required
• IRT implementation, design, and management experience required
• Prior Biopharmaceutical, pharmaceutical or chemical manufacturing experience preferred
• Creative, capable problem-solver
• Experience in establishing and maintaining relationships with vendors and attending business review meetings (Vendor oversight)
• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements
• Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)
• Successful candidate…