Director of Clinical Trial Strategy

2 weeks ago

Cork, Cork, Ireland beBee Careers Full time
Role Overview:

This position will lead a cross-functional team in the development of high-quality clinical program designs, including different design scenarios, in partnership with asset teams. The successful candidate will provide transparent costs, timelines, and risks associated with the plan.

The ideal candidate will have experience working with clinical research sites, global trials, and pharmaceutical industry knowledge relevant to clinical trial design of Phase II to IV studies.

Main Responsibilities:
  • Lead Clinical Design team in translating 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.
  • Engage other functions as determined by the asset need (e.g. Safety Committees, Regulatory, Tox/PK/ADME, TTx, Bioethics).

Clinical Plan and Trial Options and Clinical Trial Protocols:

This role requires collaboration with Clinical Development Sr. Director ensuring design options take into consideration the ability to enable accelerated delivery.


Clinical Research/Trial Packages, Execution and Support:

The Associate Director Clinical Design Trial Lead will lead the creation of risk profiles to ensure trial design has appropriate risk mitigation to enable robust data delivery.


Shared Learning and Continuous Improvement:

This position will focus on organizational learning to proactively identify, apply, and share best practices and learnings related to program and protocol design within and outside the organization.

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