Designing a clinical operating model built for the future

The why

Clinical operations play a direct role in asset value creation. Faster development timelines can extend the commercial life of an asset, thereby strengthen the value captured over the product lifecycle. At the same time, trial delivery is becoming more complex. Protocols are harder to execute, patient recruitment is more challenging, and delivery depends on stronger coordination across countries, sites, and functions. To maximise lifetime asset value, clinical operations also need to work effectively across key interfaces with medical, regulatory, R&D, commercial, and market access. This increases the importance of a clinical governance model with clear decision-makers, defined interfaces, and explicit accountability across global, regional, and affiliate levels.

The challenge

Our client was facing a growing clinical challenge as its development portfolio expanded. The clinical organisation had to support greater scale and complexity with less predictability, while more studies, new sites and investigators, and growing tensions between functions had made the model harder to run. Roles, reporting lines, and interfaces had evolved without enough clarity.

The organisation was operating across global, regional, and affiliate levels, creating ambiguity around governance, accountability, and handoffs. Leadership needed a clearer model for how portfolio priorities should translate into trial planning, country allocation, site readiness, capability building, and execution.

Outcome

Clear diagnosis of the main pain points

The work gave leadership a structured view of the key issues in the current model, including where governance was unclear, where interfaces were breaking down, and where the organisation was struggling to support trial delivery effectively at scale.

A redesigned clinical governance model

The project reshaped governance across global, regional, and affiliate levels, with clearer decision rights, stronger interfaces, and more explicit job descriptions. This created a more usable model for accountability, coordination, and execution.

Unified affiliate archetypes

The new model defined archetypes for how affiliates were structured and set-up. This reduced unnecessary variation, made local roles easier to understand, and gave the organisation a more coherent basis for managing clinical operations across affiliates.

A blueprint for translating global priorities into local delivery

We created a blueprint for clinical operations, showing how global priorities should flow into regional coordination and affiliate execution. This strengthened the link between strategic direction and day-to-day delivery.

Change management, PMO set-up, and roll-out support

Biobridge Partners supported not only the design of the model, but also the change management and roll-out needed to embed it. We helped set up and drive a PMO to coordinate implementation, support communication, track progress, and drive adoption across the organisation with greater consistency.

What moved the needle

Grounding the design in perspectives across the organisation The work was shaped through input from global, regional, and affiliate roles, which made it possible to understand where governance, interfaces, and accountabilities were breaking down in practice.

Turning governance design into practical role clarity A key success factor was translating high-level governance questions into explicit decision rights, job descriptions, and responsibilities. That made the output easier to use in practice and gave leadership a clearer basis for implementation.

Designing for adoption, not only for approval The project did not stop at defining the future model. Change management and roll-out were built into the work, which helped the organisation communicate the model clearly, support adoption across affiliates, and embed new ways of working with greater consistency.

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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