Clinical Design Lead

2 weeks ago

Cork, Cork, Ireland beBeeDesign Full time €90,000 - €120,000
Job Description:

The Clinical Design Lead role is a key position in our organization, responsible for providing clinical program and trial design leadership and expertise.

This role leads a cross-functional team in the development of high-quality designs for specified assets, including different design scenarios, in partnership with the Asset team.

  • Translate therapeutic area and asset team strategy into clear objectives and associated clinical development program and trial optionality.
  • Represent program and trial design optionality to asset teams and Sr. Leaders to inform prioritization of an option that will be translated into a clinical protocol(s).
  • Provide insight into impact of study/protocol design features to feasibility, value, patient and investigator burden, and execution speed/efficiency.

In addition, the Clinical Design Lead is responsible for working with Clinical Capabilities and Clinical Development to enable accelerated delivery.

Clinical Research/Trial Packages, Execution and Support

  • Understand how design elements influence the ability to deliver on new regulatory expectations and clinical capabilities.
  • Lead the creation of risk profiles to ensure trial design has appropriate risk mitigation to enable robust data delivery.
  • Collaborate with Clinical Development Sr. Director ensuring design options take into consideration the ability to enable accelerated delivery.

Shared Learning and continuous improvement

  • Focus on organizational learning to proactively identify, apply, and share best practices and learnings related to program and protocol design.
  • Closely collaborate with asset teams and delivery teams to understand the impact of design on speed to protocol approval and study startup.

People Development

  • Provide coaching within the organization that fosters inclusion and innovation.
  • Model the Lilly leadership behaviors.

To be successful, the candidate should have a minimum 5 years of directly related clinical trial or pharmaceutical project management experience.

A strong understanding of the clinical drug development processes is also required.

The ideal candidate should possess excellent communication and leadership skills, with the ability to work effectively in a team environment.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

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