Global Clinical Integration Lead

Job title:
Global Clinical Integration Lead

Contract: 6 months

Location:
London (hybrid)

As the Integration Lead, you will be expected to provide high impact strategic support and lead complex sub-work streams and programs of work relating to business development deals. In this role you will require significant flexibility, taking on additional responsibilities as needed covering a broad range of potential activities relating to scientific licencing and divestments.

Additionally, you will engage directly with leaders within Business Development, Clinical Operations and other Clinical Development functions to ensure the effective delivery of integration & separation activities and other projects as required, representing the interests of Clinical Operations at high level cross-functional and cross-company discussions as needed.

In this role you lead and strategically align expertise within the teams for the transitions, with the aim to drive the speed and efficiency of planning and executing transitions. You will also need to engage and work across teams within Clinical Operations and Business Development to ensure business objectives are translated into clear deliverables and that any risks are identified, quantified, managed and mitigated so that the overall business objectives are met whilst maintaining quality.

You will be responsible for facilitating workshops to define the roadmap and associated activities, ensuring clear ownership and effective coordination, and may also be required to lead the execution of selected initiatives. In addition, you will participate in broader integration forums, ensuring strong alignment and coordination with Clinical Operations activities within the wider integration landscape.

• Lead Sub-work streams and/or discrete programs of work relating to integration, divestment or partnership opportunities within Clinical Operations.
• Work in alignment with the Clinical Operations Asset Lead to ensure clear senior leadership visibility of clinical integration priorities, risks, and impacts from deals
• Lead and drive development of processes, guidance and written standards to standardise business development activities and post deal support within Clinical Operations.
• Set-up and manage Clinical Operations Integration & Separation Working group, funnelling cross functional Clinical Operations input into R&D Integration and Separation Specialist network.
• Act as study delivery SME on all matters relating to study level integration and separation and as integration and separation SME within wider Clinical Operations study delivery network.
• As needed, lead CAPA development/response to issues relating to integration/separation activities arising supported by the COAL
• As needed, partner with the clinical and operational team leader representing the Clinical Operations functions on deal teams/project teams and with external partners (setting transition strategy and ensuring a deliverable plan)

• Bachelor's degree. Scientific or Business discipline

• Experience managing global clinical trials
• Proven ability to drive process improvement in a matrix environment.
• Proven record of Project management experiences
• Exposure to written standard development and/or business development or other similar integration/separation activities (change control)
• Experience managing vendors or collaborating with external partners (CROs)
• Proven record of multi-functional collaboration skills beyond Clinical Operations to any other relevant operational or development functions
• Knowledge and understanding of Clinical Trial processes.