Are you seeking a career that makes a difference in the world? Are you an innovative thinker who can craft strategic solutions to deliver a continuously changing portfolio? Do you seek an opportunity to spearhead cross-functional design efforts in the development of innovative and high-quality trial designs? We are seeking a Immunology Clinical Development Design Hub Consultant to work with highly skilled Clinical Advisors, Physicians, Statisticians, and other experts to integrate emerging clinical design capabilities with innovative drug development practices. In this role you will
Lead Clinical Development Design Hub team in translating design requirements into refined innovative clinical plan scenarios that include optimized costs, timing, risks and program features
Ensure consistent development and finalization of complete trial packages (e.g. protocol, IB, ICD, functional documents/plans) to enable smooth transition into Execution
Support the preparation of materials that communicate design options to governance for approval by the Business Unit
Engage other functions as determined by the asset need (e.g. Safety Committees, Regulatory, Tox/PK/ADME, TTx)
Utilize external benchmark data in conjunction with the Design Hub Foundations team to develop clinical plans and clinical trial designs (e.g. country identification/allocation as well as final potential site/investigator list)
Generates ideas for new processes and drives process improvement to enhance functionality and productivity of the team
Partners closely with the Clinical Development Advisor and maintains strong communication during the development of the design for an asset
Identify technologies and capabilities to support modeling needs and to inform designs.
Especially important to the success of the group, you will provide coaching within the organization that fosters inclusion and innovation, continual improvement, and an external understanding and awareness. Additionally, you will:
Focus on organizational findings to identify and replicate best practices
Ensure drug development shared learning amongst colleagues within and outside of the Clinical Development Design Hub
Internal Number: 48689
About Eli Lilly & Company
Company Overview At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees worldwide work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.