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Director, Clinical Supplies

MBX Biosciences, Inc.
Full-time
Remote friendly (United States)
United States
Operations

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Role Summary

Director, Clinical Supplies — MBX Biosciences seeks an experienced professional to lead and optimize clinical supply chain operations supporting global clinical trials for peptide drugs. This role manages labeling, packaging, distribution, inventory control, cold chain logistics, forecasting, IRT system setup and maintenance, and external partner relationships to support global trials. The successful candidate will work cross-functionally with CMC, Clinical Operations, Program Management, Regulatory Affairs, Finance, and Quality, reporting to the SVP, Pharmaceutical Development & CMC.

Responsibilities

  • Develop and execute clinical supply strategies aligned with development timelines and program goals.
  • Execute clinical supply chain activities including labeling, packaging, distribution, inventory management, forecasting, initiation, maintenance and expiry of clinical supplies.
  • Manage relationships with external partners (CDMOs, CROs, logistics providers) to ensure timely, efficient, and compliant delivery of investigational products.
  • Lead clinical supply planning and risk mitigation to prevent disruptions and ensure continuity.
  • Liaise with stakeholders to support timely approval and execution of SOPs, batch records, lot releases, change controls, deviations, and CAPAs.
  • Ensure compliance with global regulatory requirements, GMP standards, and internal quality systems.
  • Collaborate closely with Clinical Operations, Regulatory Affairs, Quality Assurance, and CMC teams.
  • Monitor inventory levels and implement proactive supply chain solutions.
  • Contribute to vendor selection, contract negotiations, and budget management.
  • Other responsibilities as assigned.

Qualifications

  • Bachelor's or Master's in a scientific discipline with 12+ years of relevant experience in clinical supply chain and logistics.
  • Hands-on experience managing labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies.
  • Experience managing clinical supply vendors and contract manufacturers.
  • Strong clinical supply skills with the ability to track multiple activities, deliverables, timelines, contracts and budgets.
  • In-depth knowledge of quality and regulatory aspects of clinical supply chain for multi-country studies involving biologics or peptides.
  • Excellent problem-solving, strategic thinking, and ability to work in a fast-paced, collaborative environment.
  • Outstanding scientific leadership, collaboration, interpersonal skills, self-awareness, and ability to manage team dynamics.

Education

  • Bachelor's or Master's in a scientific discipline.
  • 12+ years of relevant experience in clinical supply chain and logistics.