Clinical Development Design Consultant-Immunology

Indianapolis, Indiana
April 05 2019
Life Sciences
Position Type
Full Time
Organization Type
Job Type
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

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 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 4 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.

Additional Information

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.

Additional Skills/Preferences

  • 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

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