Director, Clinical Supply

MBX Biosciences, Inc.; Burlington (MA); On-site; USD 150,000 - 210,000; Full time

Job summary

MBX Biosciences is seeking a driven professional to lead and optimize clinical supply chain operations supporting global trials for peptide drugs. You will manage labeling, packaging, distribution, inventory control, cold chain logistics, forecasting, IRT setup, and external partner relationships to ensure on-time, compliant supply.

The role involves collaboration with CMC, Clinical Operations, Regulatory Affairs, Finance, and Quality, reporting to the SVP, Pharmaceutical Development & CMC.

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 supply chain activities including 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 multi-country studies for biologics or peptides.
• Excellent problem-solving skills, strategic thinking, and ability to work in a fast-paced, collaborative environment.
• Outstanding 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 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 product launches.
• 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 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.

Skills

Cross-functional collaboration

Problem-solving

Strategic thinking

Leadership

Stakeholder management

Education

Bachelor's or Master's in a scientific discipline

12+ years clinical supply chain experience

Experience managing supply chain activities

Biologics/peptides regulatory knowledge

Tools

IRT system setup and maintenance

Job description

Position Summary

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.

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.

Key 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.

Education & Qualifications

• 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.

Travel & Location

You will be expected to travel periodically, based on business needs, including attending Together Weeks, Together Days, and functional meetings as requested by the Company. This role is expected to be on-site an average of three days per week, unless otherwise requested or additional on-site meetings require more time in the office.

Company Overview

MBX Biosciences is a biopharmaceutical company focused on the discovery, development and commercialization of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism preparing for Phase 3 development; and an obesity portfolio that includes MBX 4291 in Phase 1 development and MBX 5765 in preclinical development, as well as additional discovery candidates. The Company is based in Carmel, Indiana and Burlington, Massachusetts. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.

EEO Statement

MBX Biosciences is an Equal Opportunity Employer and is committed to treating all applicants fairly without discrimination. We welcome applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law.