Transformation & Organizational Capability / Service
Operating model review, governance for cross-functional and digital initiatives, site strategy input, and improvement of how regulatory, R&D, quality, and commercial functions work together — grounded in experience leading R&D operations for organizations representing 2,000+ scientists.
The Work
At scale, the regulatory–R&D–quality–commercial interface is where most innovation programs slow down. A pipeline review approves a project. R&D scopes the formulation. Regulatory flags a downstream pathway issue six months later. Quality identifies a specification gap at validation. Commercial discovers a claims constraint after the brief is locked. Each function did its job; the system did not. The cost is not a single missed milestone — it is a portfolio that consistently arrives late, off-claim, or off-budget.
Site strategy compounds the problem. Decisions about where capability lives, which sites get which categories, how technology transfer is governed, and how acquired sites are integrated have first-order effects on speed, cost, and capability. Yet these decisions are often made under transaction pressure, without a structured view of how the change reshapes the operating model the rest of the business is going to live with for the next decade.
Cross-functional governance for digital and AI initiatives is the newest version of this same pattern. R&D launches a data-science effort. Regulatory is brought in late, after model choices have already constrained validation paths. IT and quality argue over data lineage. Commercial questions whether the use case maps to a real business decision. Without governance designed for these initiatives specifically, the work stalls or ships in a form that no one is comfortable defending.
RGM brings direct operating experience to this work. The founder led R&D operations for North America at Sanofi, with responsibility for organizations representing more than 2,000 scientists across multiple sites and categories — including the practical reality of integrating acquired R&D footprints, governing cross-functional digital initiatives, and aligning regulatory, R&D, quality, and commercial leadership around shared portfolio decisions. That experience is the difference between a generic operating-model review and one that holds up when the work actually starts.
Heads of R&D operations, R&D leaders post-acquisition, organizations rationalizing R&D footprint, or companies launching digital/AI initiatives inside R&D.
A documented R&D operating model assessment, a governance framework for cross-functional initiatives, site-strategy options with trade-offs, and an integration playbook for R&D M&A.
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