Clinical Supply Lead

Gates Foundation • Cambridge, MA

1d • Hybrid

About The Position

The Clinical Supply Lead is responsible for clinical supply strategy, planning, integration, and oversight across Gates MRI development programs and clinical studies. Reporting to the Pharmaceutical Process Development Leader, the role represents clinical supply on program and study teams and works closely with Clinical Operations, CMC, Manufacturing, Quality Assurance, Regulatory Affairs, Project Management, and external service providers.

Responsibilities cover demand and supply planning; finished-goods manufacturing and packaging; labeling; inventory management; and global clinical distribution. Within Gates MRI’s outsourced delivery model, the lead provides direction, inputs, decisions, cross-functional alignment, oversight, and governance to ensure service-provider activities are appropriately planned, compliant, and delivered in support of patient dosing and study continuity.

The position is based in Cambridge, Massachusetts. Flexible arrangements are offered for local candidates, with 50% on site; remote arrangements are not available. A competitive relocation package is available for candidates moving to the area.

Requirements

• Bachelor’s degree in a relevant discipline.
• 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 with outsourced clinical supply models, including management and oversight of CMOs, CROs, and other external service providers.
• Experience in clinical supply planning, packaging, labeling, inventory management, and global distribution.
• Working knowledge of cGMP requirements, GxP principles, and applicable regulatory guidance.
• Ability to collaborate across clinical, CMC, manufacturing, quality, regulatory, project management, and external partner organizations.
• 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 work effectively in a dynamic development environment.

Nice To Haves

• An advanced degree or MBA.

Responsibilities

• Lead and influence blended internal and external teams, establishing clear expectations and accountability and supporting collaborative problem-solving and effective governance.
• Serve as the primary Gates MRI clinical supply interface with external service providers and vendors, clarifying responsibilities, decision rights, escalation pathways, and 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 governance channels.
• Establish and maintain demand assumptions with Clinical Operations, CMC, and Project Management, and ensure changes to study design or execution are reflected promptly in supply plans.
• Ensure packaging, labeling, and distribution strategies 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 adequate clinical supply 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 with Clinical Operations and other functions operating through outsourced models to align study execution assumptions and clinical supply plans.
• Ensure clinical supply activities comply with applicable GxP, regulatory, quality, and Gates MRI requirements, with appropriate documentation and inspection readiness.
• Manage clinical supply impacts arising from portfolio, program, protocol, regulatory, or organizational changes and incorporate revised requirements into plans promptly.
• Promote operational excellence through metrics, risk indicators, lessons learned, knowledge transfer, and continuous improvement.

Benefits

• Competitive relocation package for candidates moving to the Cambridge, Massachusetts area.
• Flexible work arrangements for local candidates (50% on site).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior