Clinical Design Lead: A Key Role in Pharmaceutical Development
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At Eli Lilly, we are committed to making life better for people around the world. Our global healthcare leader is headquartered in Indianapolis, Indiana, and our employees work together to discover and bring life-changing medicines to those who need them. We improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
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The Associate Director Clinical Design Trial Lead role is a key position in our organization. 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. The Clinical Design Trial Lead provides transparent costs, timelines, and risks associated with the plan to the Asset team. Additionally, this role works with Clinical Capabilities and Clinical Development to enable accelerated delivery.
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Responsibilities:
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* Lead Clinical Design team in translating therapeutic area and asset team strategy into clear objectives and associated clinical development program and trial optionality.
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* 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).
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* Provide insight into impact of study/protocol design features to feasibility, value, patient and investigator burden, and execution speed/efficiency.
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* Engage other functions as determined by the asset need (e.g. Safety Committees, Regulatory, Tox/PK/ADME, TTx, Bioethics)
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* Utilize external benchmark data in conjunction with the Clinical Design Capabilities in the development of clinical plans and clinical trial designs.
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* Understand how design elements influence the ability to deliver on new regulatory expectations and clinical capabilities.
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* Lead the creation of risk profiles to ensure trial design has appropriate risk mitigation to enable robust data delivery.
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* Collaborate with Clinical Development Sr. Director ensuring design options take into consideration the ability to enable accelerated delivery.
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* Ensure consistent development and finalization of documents that support the complete trial package to enable smooth transition into delivery.
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* Focus on organizational learning to proactively identify, apply, and share best practices and learnings related to program and protocol design.
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* Closely collaborate with asset teams and delivery teams to understand the impact of design on speed to protocol approval and study startup.
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* Work closely with counterparts in Clinical Design and therapeutic areas to generate ideas and continue to evolve Lilly standards, tools, and best practices that span drug development.
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* Provide coaching within the organization that fosters inclusion and innovation.
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* Model the Lilly leadership behaviors.
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* Apply innovation and lessons learned in real time.
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Requirements:
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The ideal candidate will have a Bachelor degree in a scientific or health-related field. They will have a minimum of 5 years of directly related clinical trial or pharmaceutical project management experience. Demonstrated knowledge and experience with project management tools and processes are also required.
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A strong understanding of the clinical drug development processes, experience working at and/or with clinical research sites, and previous experience in the management of global trials are preferred. The ability to anticipate and resolve key technical, operational, or business problems is also essential.
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