Diabetes Therapeutic Design Consultant
The Therapeutic Area Design Consultant independently leads a cross-functional design team in the development of a high quality design for a specified asset(s), including different design scenarios, in partnership with the Asset team. This includes providing to the Asset team transparent costs, timelines, and risks associated with the plan. Additionally, in this role you are responsible for working with the Design Advisor, Design CRP, Design Capabilities Hub and Site Engagement to deliver a complete trial package to the Asset team to ensure smooth transition to execution. You will integrate clinical design capabilities and best drug development practice with therapeutic and phase specific focus and expertise.
Other responsibilities include:
- Collaborates with Clinical Development Advisor on clinical plan and trial design topics
- Provides input for implementing the asset strategy via the clinical plan
- Ensure consistent development and finalization of complete trial packages (e.g. protocol, IB, ICD, functional documents/plans) to enable smooth transition into Execution
- Leads Design Hub team in translating design requirements into refined innovative clinical plan scenarios that include optimized costs, timing, risks and program features
- Supports the preparation of materials that communicate design options to governance for approval by the Business Unit
- Engages other functions as determined by the asset need (e.g. Safety Committees, Regulatory, Tox/PK/ADME, TTx)
- Utilizes external benchmark data in conjunction with the Design Capabilities Hub in the development of clinical plans and clinical trial designs (e.g. country identification/allocation as well as final potential site/investigator list)
- Partners closely with the Clinical Development Advisor and maintains strong communication during the development of the design for an asset
- Provide coaching within the organization that fosters inclusion and innovation, continual improvement, and an external understanding and awareness
- Model the Lilly leadership behaviors
Shared learning and continuous improvement
- Focus on organizational learnings to identify and replicate best practices
- Closely partner with the Design Hub Capability team to
- Identify and secure necessary data sources (historical trial, country, site, pricing etc.) to support current and upcoming TAs
- Identify and apply capabilities to help inform designs (e.g. CoLAB)
- Generates ideas for new processes and drives process improvement within the Design Hub to enhance functionality and productivity of the team
- Partner with the Design Hub Advisors and Leaders to identify technologies and capabilities to support modeling needs
- Ensure drug development shared learning amongst colleagues within and outside of the Design Hub
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 around the world 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.Basic Qualifications
- Bachelor degree, preferably in a scientific or health-related field
- Minimum 5 years of directly related clinical trial or pharmaceutical project management experience
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
- Knowledge of the diabetes therapeutic area.
- Demonstrated knowledge and experience with project management tools and processes
- Previous experience in leading drug development teams
- Strong communication skills.
- Post-graduate degree (e.g. Pharm D, M.S., or Ph.D.)
- A strong understanding of the clinical drug development processes and the interdependencies of the various tasks/functions
- Experience working at and/or with clinical research sites
- Demonstrated ability to influence team members and extended team members
- Ability to anticipate and resolves key technical, operational, or business problems
- Ability to drive solutions affecting results within a business area
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.