The posting
“We are focused on results. Those that can be measured. And those measured in ways beyond numbers. We see individuals, not issues. We are inspired by passion, and compassion for the wellbeing of people. Our methods are based on logic, driven by rigor, results, issues, and outcomes. Our innovation means trying new things, learning from our mistakes, and consistently refining our approach. Our strategies help us define our path to success, but our effectiveness is based in the aggregate power of our initiatives to impact holistic change.”
-Bill Gates
The Gates Medical Research Institute (Gates MRI) is a non-profit biopharmaceutical development organization primarily dedicated to the development of impactful biopharmaceutical interventions for diseases that disproportionately affect the world’s poorest populations, diseases that combined cause five deaths every minute. Headquartered in Cambridge MA, the Institute is designed to advance novel drug, biologics, and vaccine candidates through late-stage development and registration. The Institute encompasses experienced biopharmaceutical development professionals across regulatory, CMC, and clinical functions as well as comprehensive operational support functions. The Institute’s programs are managed by its internal teams and functional areas in collaboration, working with partners across the global health ecosystem.
The Institute is based on five core “mantras” that are embedded within the organization and its people:
- Urgency: Execute with excellence to maximize impact.
- Collaboration: Establish empowered teams to drive our bottom line: lives saved.
- Innovation: Build on the known, uncover the new, achieve the unprecedented.
- Rigor: Drive the science, focus on the details, and execute with the highest quality.
- Courage: Dare to confront the world’s most significant global health challenges.
Though the Institute is a diverse group of passionate change-makers, creative fixers, and relentless advocates, these five core values are universally adopted by all who join it with the personal goal of improving the health and wellness of the world’s most vulnerable populations.
As a wholly owned subsidiary and separate legal entity of the Gates Foundation, the Institute partners scientifically, operationally, and financially with the foundation to leverage the foundation’s ongoing support and contributions toward the achievement of global health equity.
The Institute MRI offers flexible work arrangements for local candidates (50% on site) and a competitive relocation package for those looking to move to the Cambridge, MA area for this on-site role. Remote arrangements are not available at this time for this role.
THE POSITION
Reporting 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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Hiring Requirements
As part of our standard hiring process for new employees, employment will be contingent upon successful completion of a background check.
Candidate Accommodations
We’re committed to providing an inclusive and accessible hiring experience for all candidates. If you have a disability or medical condition and need an accommodation at any stage of the application or interview process—such as an ASL interpreter, alternative interview format, or physical accessibility support—we’re happy to help. Please contact [email protected] with the position number and a brief description of your accommodation needs. Requests will be handled confidentially.
Inclusion Statement
We are dedicated to the belief that all lives have equal value. We’re committed to creating a workplace where employees thrive both personally and professionally. We also believe our employees should reflect the rich diversity of the global populations we aim to serve—in race, gender, age, cultures and beliefs—and we support this diversity through all of our employment practices.
All applicants and employees who are drawn to serve our mission will enjoy equality of opportunity and fair treatment without regard to race, color, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender expression, national origin, genetic information, veteran status, marital status, and prior protected activity.
