Clinical Supply Lead
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 partners with Clinical Operations, CMC, Manufacturing, Quality Assurance, Regulatory Affairs, Project Management, and external service providers. Within Gates MRI’s outsourced delivery model, external service providers perform defined operational activities. The Clinical Supply Lead provides direction, inputs, decisions, cross-functional alignment, oversight, and governance to ensure those activities are appropriately planned, compliant, and delivered in support of patient dosing and study continuity. The scope includes demand and supply planning, finished-goods manufacturing and packaging, labeling, inventory management, and global clinical distribution. This is an on-site role in Cambridge, Massachusetts. Flexible arrangements are available for local candidates, with 50% on-site work; remote arrangements are not available. A competitive relocation package is offered to candidates relocating to the Cambridge area.
Requirements
- Bachelor’s degree in a relevant discipline.
- 10–15 years of progressive clinical supply experience in the pharmaceutical, biotechnology, or vaccine industry.
- Demonstrated experience managing clinical supply for international clinical studies.
- Strong experience in 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.
- Ability to collaborate effectively 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
- Advanced degree or MBA.
Responsibilities
- Lead or influence blended internal and external teams, 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, establishing 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 with Clinical Operations, CMC, and Project Management, ensuring changes in study design or execution are rapidly reflected 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 sufficient 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, and maintain appropriate documentation and inspection readiness.
- Manage clinical supply impacts arising from portfolio, program, protocol, regulatory, or organizational changes and incorporate revised requirements into plans in a timely manner.
- Promote operational excellence through meaningful metrics, risk indicators, lessons learned, knowledge transfer, and continuous improvement.
Benefits
- Flexible work arrangements for local candidates, with 50% on-site work.
- Competitive relocation package for candidates moving to the Cambridge, Massachusetts area.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
