Designing a global clinical operating model for the future

The why

The pharmaceutical industry is under significant transformation pressure to shorten development timelines, increase R&D productivity, and build the flexibility needed to competitively deliver global trial portfolios. Clinical operations leaders need to transform how work is done at global scale, while at the same time protecting delivery of the active portfolio. Clarity of roles & responsibilities and fit-for-purpose governance with clear accountability from global-to-local is critical to succeed with orchestrated transformation and execution across the value chain from trial planning, through startup, and into execution.

The challenge

Our client was facing increasing complexity in global trial delivery and organisational friction driven by an expanding development portfolio and a decentral governance model, which was put under pressure by the need to build new capabilities and expand global footprint. There was a need to clarify global roles & responsibilities and mandates, and to streamline and standardise structures and interfaces across global, regional, and local teams to ensure a model fit for the future.

How we helped

We supported leadership reshape the operating model with an outset in a thorough assessment of pain points, and the development of tangible recommendations for reducing organisational complexity and driving global unity. As part of this scope, we addressed the clinical governance model, global roles & responsibilities, and organisational structures based on archetypes to create clarity of global-local interfaces and collaboration fora. Following EVP approval, we supported the roll-out of the global model across 50+ countries.

Outcome

Focused investments based on country archetypes

Clear choices for where to invest and where to wind down to reduce global complexity and achieve scale in global capabilities, and execution of those choices in global roll-out across 50+ countries.

Global simplification of structures and ways of working

Streamlined global ways of working based on archetype structures, e.g., for study-startup and operations excellence functions, global role descriptions, and clarification of local roles and interfaces to global teams, as documented in the Clinical Blueprint.

Strengthened reporting lines and mandates

The new model defined global mandates to enable continuous transformation and global improvements from new ways of working and technology-enablement, ensuring a continuous focus on delivering global clinical excellence.

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 identify 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 structural requirements, decision rights, job descriptions, and behavioral expectations. That made the output applicable in practice and gave leadership a clear basis for implementation.

Mobilising the organisation early for implementation success We supported mobilising leaders across the organisation, ensuring executive sponsorship and organisational buy-in with relevant structures, e.g., a sounding board of local leaders part of the design phase, who were later made accountable for implementation.

Partner

Jonas Karlsen

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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