Clinical Supply Chain Manager

Reports to: Senior Director, Global Supply Chain & Logistics

Position Summary

This position is responsible for ensuring 100% availability of Fractyl’s study-specific materials at clinical trial sites, when needed. The study-specific materials include Fractyl-manufactured single use devices and patient facing supplies including glucose monitors, eCOA tablets, Tirzepatide, and weight scales. Proficiency is required in inventory management within clinical inventory management databases/software, as well as ERP systems. Superior communication skills and the ability to interface cross functionally throughout the Fractyl organization are requirements. This is an on-site/non-remote position.     

Primary Responsibilities

• Ensure case day availability of Fractyl-manufactured single use devices by establishing and maintaining “buffer” stocks at all US and International clinical sites. Monitor inventory at clinical sites, Fractyl’s third party logistic provider (3PL) and Fractyl’s internal stock location, and direct shipments accordingly to maintain appropriate stock levels at each location. Work with cross-functional team members, and the VP Manufacturing to estimate demand forecasts.
• Effectively direct shipments of Fractyl’s single use devices to third party logistics provider (3PL) and to Fractyl’s partnering clinical sites. Establish and maintain relationships with the sites’ study coordinators and/or nurse managers to ensure that all single use devices are “in-hand” and available on case day.
• Effectively manage the relationship with suppliers of patient facing supplies. Understand lead times, establish and maintain buffer stocks based on supply risk and financial cost. Proactively solve supply issues.
• Manage inventory in two databases (Fracty’s ERP system for financial reporting and the clinical/FDA auditable database/software). With 100% accuracy, add inventory upon receipt and deduct upon consumption.
• Establish metrics and consistently report status to Sr Management.
• For shipments directly from Fractyl, prepare all required documentation for shipment both domestically and internationally.
• As required, author or modify procedures that govern the effective supply of clinical product. Ensure compliance with international ICH/Good Clinical Practice (GCP) guidelines/regulations.
• Participate in project meetings such as internal team discussions and CRO/vendor meetings, etc.
• Generate meeting minutes/action items for project team meetings related to study supply management.
• Assist with identifying and implementing best practices, seeking continuous process improvements as appropriate.
• Support field-based employees with shipments of field replaceable units (FRUs) on an urgent and emergency on-call basis as required by case cadence.
• Liaise with sites, vendors, CROs, internal study team, and others, communicating clearly, effectively and in a timely fashion.
• Perform all activities in compliance with applicable regulations, Fractyl’s policies, and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.
• Bring a “can do” spirit to work and deliver on other responsibilities as assigned.

Education or Certification Requirements

• Bachelor’s degree in scientific or business field of study

Professional Work Experience

• 5+ years of hands-on experience managing the supply chain of clinical product.
• Direct experience with inventory management systems (ERP and clinical inventory management software). Working knowledge of Microsoft D365, RSTM or Zelta will be considered a plus.
• Experience collaborating with cross-functional teams, including field service, clinical operations, and manufacturing.
• Proven ability to manage site-level inventory, ensuring investigational products and related study supplies are in stock and ready for distribution.
• Strong communication skills with a track record of effectively liaising with sites, vendors, CROs, and internal stakeholders.
• Applicable experience in biotech, pharmaceutical, and/or medical device industries required.
• Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).

Other Essentials and Key Success Factors

• Successful track record of working in high-growth and dynamic organizations
• Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
• Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
• Evidence of "hands-on" experience and expertise
• Proven and successful track record as a team-player and collaborator in small working environments
• Highly organized and detail oriented with a passion to deliver quality results
• Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
• Highest levels of professionalism, confidence, personal values and ethical standards

Travel

• This position requires 0-5% travel as needed.

The description and requirements outlined above are general; additional requirements may apply.