Director, Clinical Supply

MBX Biosciences•Burlington, MA

2d•Hybrid

About The Position

MBX Biosciences is looking for a driven and experienced professional to lead and optimize clinical supply chain operations supporting global clinical trials for our growing portfolio of peptide drugs. In this role, you will manage key activities including labeling, packaging, distribution, inventory control, cold chain logistics, forecasting, IRT system setup and maintenance, and managing relationships with our external partners to support global clinical trials. Additionally, you will play a key role in advancing commercial supply readiness and supporting product launch planning and execution as programs progress toward commercialization. The ideal candidate thrives in a fast-paced, collaborative environment and excels at building strong cross-functional relationships with teams across CMC, Clinical Operations, Program Management, Regulatory Affairs, Finance, and Quality. This individual will report directly to our SVP, Pharmaceutical Development & CMC, and will collaborate cross-functionally to drive operational excellence and innovation in clinical supply management.

Requirements

Bachelor's or Master's in a scientific discipline with 12+ years of relevant experience in clinical supply chain and logistics.
Must have hands-on experience managing supply chain activities including but not limited to 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 operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets.
In-depth knowledge of quality and regulatory aspects of clinical supply chain in support of complicated multi country clinical studies for biologics or peptides.
Excellent problem-solving skills, strategic thinking, and ability to work in a fast-paced, collaborative environment.
Outstanding scientific leadership and collaboration skills.
Outstanding interpersonal skills, self-awareness, and ability to manage team dynamics.

Responsibilities

Develop and execute clinical supply strategies aligned with MBX’s development timelines and program goals.
Execute clinical supply chain activities, including but not limited to labeling, packaging, distribution, inventory management, forecasting, initiation, maintenance and expiry of clinical supplies.
Lead commercial supply readiness activities, including supply planning, inventory strategy, distribution readiness, and cross-functional coordination to support successful product launches and commercialization efforts.
Manage relationships with external partners, including CDMOs, CROs, and logistics providers to ensure timely, efficient, and compliant delivery of investigational products.
Lead clinical supply planning and risk mitigation efforts 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.