Setting up a PMO to roll-out a global clinical operating model

The why

Operating model redesign only creates value when it is adopted in practice. The larger the organisation, the larger the challenge becomes. Changes to governance, roles, and decision-making must be implemented across global, regional, and affiliate levels without slowing operations, weakening accountability, or creating confusion across critical interfaces. A strong PMO can provide the governance, sequencing, and execution discipline needed to turn design into adoption.

The challenge

Our client needed to implement a new clinical operating model across a complex global organisation. The change affected governance, roles, interfaces, and ways of working across multiple levels, with implications for how decisions were made, how priorities were translated into action, and how teams worked together in practice.

The challenge was to roll out the new model quickly across multiple regions and affiliates without materially disrupting day-to-day clinical operations. Leadership needed a structure that could drive consistent implementation of new ways of working at pace, while managing dependencies, maintaining business continuity, and avoiding local variation that would weaken the model during roll-out.

Outcome

A lean PMO to drive implementation

We drove a PMO that gave the organisation a clear structure for coordinating implementation, managing dependencies, and driving adoption of the new operating model across regions and affiliates. The set-up was designed to provide enough governance and momentum without creating unnecessary burden on the business.

Timely global roll-out without disrupting delivery

The PMO enabled a timely roll-out of the new operating model across multiple regions and affiliates, while limiting disruption to day-to-day clinical operations. This helped the organisation implement new ways of working globally without negative impact on affiliate performance KPIs.

A more controlled path to adoption

By creating clear ownership, implementation discipline, and visibility on progress, the PMO gave leadership a more reliable way to embed the model consistently across the organisation rather than leaving roll-out to local interpretation.

What moved the needle

Anchoring the PMO in the actual needs and risks The project design connected global, regional, and affiliate perspectives early, which made it easier to surface implementation risks, clarify ownership, and create a PMO structure that matched how the organisation operated.

Combining governance design and change support The PMO worked because governance, communication, and change management support were designed together rather than treated as separate tracks. That gave leadership a more coherent mechanism for guiding the roll-out.

Creating a lean PMO with limited impact on day-to-day delivery A key success factor was designing the PMO to be lean, focused, and practical. It provided enough structure to coordinate implementation and support adoption, while keeping demands on the business manageable and limiting disruption to ongoing clinical operations.

Partner

Jonas T. Karlsen, Ph.D.

Jonas is a life science strategist supporting executives drive progress across the value chain. He is an expert in bridging strategy and execution via global operating model design and transformation rooted in strategic objectives. He engages with structured top-down thinking and a pragmatic and collaborative approach to mobilise organizations and make things happen.

Jonas holds a Ph.D. in biophysics from the Technical University of Denmark, DTU, and further studied at California Institute of Technology. Recipient of the Ministry of Sciences Elite Research Award.

Selected experience

Ecosystem integration and external innovation pipeline
Lab of the future capability building and operating model design
Global clinical operating model design and transformation
Pre-launch strategy for cardiometabolic TA development

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