Consultant, Design Hub Therapeutic Area Project Management

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.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 transparent costs, timelines, and risks associated with the plan. In addition, the Design Consultant will work with the Design Advisor, Design CRP, Design Hub Foundations and Site Engagement to deliver a complete trial package to the Asset team to ensure smooth transition to execution. The Consultant will integrate clinical design capabilities and best drug development practice with therapeutic and phase specific focus and expertise.Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.Clinical DesignCollaborates with Clinical Development Advisor on clinical plan and trial design topicsProvides input for implementing the asset strategy via the clinical planEnsure consistent development and finalization of complete trial packages (e.g. protocol, IB, ICD, functional documents/plans) to enable smooth transition into ExecutionLeads Design Hub team in translating design requirements into refined innovative clinical plan scenarios that include optimized costs, timing, risks and program featuresSupports the preparation of materials that communicate design options to governance for approval by the Business UnitEngages 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 assetPeople DevelopmentProvide coaching within the organization that fosters inclusion and innovation, continual improvement, and an external understanding and awarenessModel the Lilly leadership behaviorsShared learning and continuous improvementFocus on organizational findings to identify and replicate best practicesClosely 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 TAsIdentify and apply capabilities to help inform designs (e.g. CoLAB)Generates ideas for new processes and drives process improvement within the Design Hub to improve functionality and efficiency of the teamPartner with the Design Hub Advisors and Leaders to identify technologies and capabilities to support modeling needsEnsure drug development shared learning amongst colleagues within and outside of the core teamPassionate about improving technological solutions using new technologiesMinimum Qualification Requirements:Bachelor degree, preferably in a scientific or health-related fieldMinimum 3 years of directly related clinical trial or pharmaceutical project management experienceOther Information/Additional Preferences:Previous experience in leading drug development teamsStrong communication skills (both verbal communication as well as written)Demonstrated knowledge and experience with project management tools and processesPost-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/functionsDemonstrated ability to influence team members and extended team members without authorityAbility to anticipate and resolves key technical, operational, or business problemsAbility to drive solutions affecting results within a business areaAbility to balance multiple activities, prioritize and manage ambiguityEli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.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. Ripple Media

Full Time

 

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