Global Clinical Supply Lead

Gates Medical Research Institute; Cambridge (MA); On-site; USD 209,000 - 324,000; Full time

Job summary

Gates Medical Research Institute in Cambridge, MA, seeks a Clinical Supply Lead to direct end‑to‑end clinical supply strategy, planning, and distribution across programs. You will partner with Clinical Operations, CMC, Manufacturing, Quality, and vendors to ensure compliant, timely supply for patient dosing and study continuity.

The role emphasizes cross‑functional collaboration, governance, and continuous improvement within a fast‑paced, mission‑driven environment.

Qualifications

• Bachelor's degree in a relevant discipline required; advanced degree or MBA is a plus.
• 10-15 years of progressive experience in clinical supply within the pharmaceutical, biotechnology, or vaccine industry.
• Demonstrated experience managing clinical supply for international clinical studies.
• Strong experience operating within outsourced clinical supply models, including management and oversight of CMOs, CROs, and other external service providers.
• Experience across clinical supply planning, packaging, labeling, inventory management, and global distribution.
• Working knowledge of cGMP requirements, GxP principles, and applicable regulatory guidance.
• Proven ability to collaborate effectively across clinical, CMC, manufacturing, quality, regulatory, project management, and external partner organizations.
• Demonstrated ability to influence and drive accountability without direct authority.
• Strong analytical, organizational, problem‑solving, and communication skills.
• Collaborative, pragmatic, and solutions‑oriented approach, with the ability to operate effectively in a dynamic development environment.

Responsibilities

• Lead and/or influence blended teams of internal and external resources, driving accountability and results through clear expectations, collaborative problem solving, and effective governance.
• Serve as the primary Gates MRI clinical supply interface with external service providers and vendors, ensuring clear responsibilities, decision rights, escalation pathways, and effective ways of working.
• Oversee external partner performance against agreed milestones, service expectations, KPIs, and KRIs; identify trends and performance gaps and drive corrective actions through appropriate governance channels.
• Establish and maintain demand assumptions in partnership with Clinical Operations, CMC, and Project Management, and ensure material changes in study design or execution are rapidly reflected in supply plans.
• Ensure packaging, labeling, and distribution strategies appropriately address clinical, regulatory, quality, blinding, country, site, and timeline requirements.
• Oversee Investigational Product and Non‑Investigational Product supply activities, including finished‑goods manufacturing and packaging, labeling, inventory management, and global clinical distribution.
• Ensure sufficient clinical supply is available to maintain dosing and study continuity by anticipating risks, evaluating mitigation options, and driving timely cross‑functional decisions.
• Lead resolution and escalation of clinical supply issues, including demand changes, inventory constraints, manufacturing or packaging delays, labeling changes, distribution challenges, and expiry risks.
• Coordinate closely with Clinical Operations and other functions operating through outsourced models to maintain alignment between study execution assumptions and clinical supply plans.
• Ensure clinical supply activities comply with applicable GxP, regulatory, quality, and Gates MRI requirements and maintain appropriate documentation and inspection readiness.
• Manage clinical supply impacts arising from portfolio, program, protocol, regulatory, or organizational changes and ensure revised requirements are incorporated into plans in a timely manner.
• Promote operational excellence through meaningful metrics, risk indicators, lessons learned, knowledge transfer, and continuous improvement.

Skills

Leadership

Collaboration

Problem-solving

Communication

Education

Bachelor's degree in a relevant discipline

Advanced degree or MBA a plus

Job description

Gates Medical Research Institute in Cambridge, MA, seeks a Clinical Supply Lead to direct end‑to‑end clinical supply strategy, planning, and distribution across programs. You will partner with Clinical Operations, CMC, Manufacturing, Quality, and vendors to ensure compliant, timely supply for patient dosing and study continuity.

The role emphasizes cross‑functional collaboration, governance, and continuous improvement within a fast‑paced, mission‑driven environment.