The mandate
Ultragenyx needed patient- and site-facing digital capabilities that could support unusual rare-disease research requirements and operate within a regulated clinical environment. Kevin joined in January 2019 and founded the Innovation Lab within Global Development Operations. His initial work included longitudinal research and patient-reported data in X-linked hypophosphatemia. He turned the opportunity for better digital patient engagement into an executive business case for an internal development capability.
The resulting organization combined the work normally spread across product teams, technology vendors, validation functions, and participant-support operations. Kevin’s remit extended from deciding what to build to ensuring that studies, sites, patients, and support teams could use it.
Organization and financial responsibility
Kevin recruited, organized, and led a distributed team spanning product ownership, business analysis, clinical informatics, solution architecture, software engineering, QA, computer system validation, vendor management, and service delivery. His later career record describes an organization of up to 54 staff. An earlier CV snapshot records 38 people and a $9 million departmental budget; subsequent career materials describe an annual budget approaching $10 million. These are different points in the organization’s development.
He owned prioritization, product roadmaps, resource allocation, operating cadence, delivery accountability, stakeholder engagement, performance management, and executive reporting. The scope required balancing reusable platform investments against study-specific deadlines and the support requirements of systems already in operation.
From an idea to an institutional capability
The Innovation Lab grew from early prototyping and a small internal team into an organization capable of designing, validating, deploying, and supporting clinical applications. Kevin established intake and governance routines, staffed specialist functions, and connected delivery decisions to study needs. He worked across Clinical Development, Clinical Operations, Data Management, QA, Vendor Performance Management, and external partners.
His leadership included mentoring colleagues to conduct buy-versus-build analyses and to source or develop electronic clinical outcome assessment capabilities. Establishing the function meant creating an operating model for repeated delivery rather than treating every study as an isolated software project.
Clinical and executive interfaces
Kevin participated in Operations Leadership and Strategic Leadership teams and served as a technology-feasibility representative on protocol development teams. His contributions addressed endpoint strategy, participant and site experience, operational risk, device integration, and the feasibility of turning scientific requirements into usable systems. His reporting line sat within Global Development Operations.
The organization supported natural-history and disease-monitoring work, Phase II–III interventional trials, and Phase IV programs. Rarify became a central example of the internal platform strategy. The broader portfolio included metabolic and bone diseases, connected devices, participant engagement, and near-real-time clinical and operational data.
Results and operating significance
The career record documents deployment of Rarify, expansion of service delivery, and a pre-pivotal Phase III audit of the digital clinical environment with zero findings. The audit result is reported in Kevin’s career documents; the underlying audit report is not a public attachment.
This work demonstrates responsibility for organizational design and sustained execution in addition to technology strategy. It connects the executive questions—investment, staffing, priorities, governance, and delivery performance—to the practical questions of how a participant uses a device, how a site receives data, and how a quality team evaluates a release.
Sources and record basis
- Conference abstractMolecular Genetics and Metabolism · ACMG 2021 supplement, eP029
The LC-FAOD disease-monitoring-program abstract lists Kevin McMahon among its authors. It is a conference abstract in an indexed supplement, not a full outcomes paper.
Kevin led an organization of up to 54 staff. The archive does not establish that all 54 were direct reports. Kevin’s career record documents a globally distributed organization of up to 54 staff. Compare that organizational scope with the size and structure your role requires.