THE POSITIONReporting to the Pharmaceutical Process Development Leader, the
Clinical Supply Lead is responsible for clinical supply strategy, planning, integration, and oversight across all Gates MRI development programs and clinical studies. The role represents clinical supply on program and study teams and partners closely with Clinical Operations, CMC, Manufacturing, Quality Assurance, Regulatory Affairs, Project Management, and FSPs. Responsibilities span demand and supply planning, finished-goods manufacturing and packaging, labeling, inventory management, and global clinical distribution.
In Gates MRI's outsourced delivery model, the FSP performs defined operational activities. The Clinical Supply Lead provides the Gates MRI direction, inputs, decisions, cross-functional alignment, oversight, and governance required to ensure those activities are appropriately planned, compliant, and delivered in support of patient dosing and study continuity.
KEY 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.
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.
In recognition of high-wage market differences such as the Cambridge, MA area where this position is located, the salary range for this role is $209,100 to $324,100.
As a mission-driven organization, we strive to balance competitive pay with our mission. New hires salaries are typically between the range minimum and the salary range midpoint. Actual placement in the range will depend on a candidate's job-related skills, experience, and expertise, as evaluated during the interview process.
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