Associate Director, Clinical Supplies Project Manager

Moderna is a biotechnology company focused on developing mRNA technology for medicine. The Associate Director, Clinical Supplies Project Manager is responsible for overseeing and leading clinical supply activities, ensuring effective supply management and collaboration across teams to meet study needs.

Responsibilities:

• 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

Requirements:

• At least 8 years of clinical supply management experience in a clinical research environment
• Bachelor's degree in a science-based subject
• Prior Cold Chain distribution experience required
• IRT implementation, design, and management experience required
• 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 will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas. Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes
• Prior Biopharmaceutical, pharmaceutical or chemical manufacturing experience preferred
• Advanced degree preferred