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Senior/Executive Director-Value, Evidence and Outcomes (VEO) – (Center of Innovation (COI)) -

Employer
Eli Lilly and Company
Location
Remote, Indiana
Start date
Mar 29, 2023

Job Details

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 35,000 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 demand for high quality health economic and outcomes research (HEOR) and real-world evidence (RWE) to support drug development, health technology assessment/access decisions, product differentiation, and clinical decision making continues to increase.  The purpose of the Lilly Value, Evidence, and Outcomes (VEO) team is to accelerate equitable patient access and transform healthcare delivery through the execution and communication of bold, high impact science.  We are looking for talented, energetic, creative, diverse, influential, and collaborative team members to join the VEO function and Team Lilly.

The VEO Center of Innovation (COI) is the central capability of real-world data/evidence (RWD/E) within Lilly. The Senior /Executive Director (SD/ED) – COI Innovative Evidence & Policy serves as an RWE policy expert and scientific leader with a deep understanding of regulatory decision-making of leveraging RWE. The SD/ED will partnership with VEO BU to identify opportunities within integrated evidence generation (IEG) to optimize value of RWE to support regulatory decision making.  

The SD/ED will report to the COI AVP Strategy Lead and work across VEO and Team Lilly to operationalize VEO COI strategic plans and to drive the development of organization capability in scoping and designing of scientifically rigorous, innovative evidence research incorporates innovative study designs, and lead upskilling in the organizational capabilities in designing and execution of innovative evidence trials. The SD/ED will lead the development of policy initiatives and external partnerships with health care systems to co shape regulatory policies and external environment, and to enable the development and execution of innovative evidence research.

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.

Innovative Evidence for Regulatory Decision Making

  • Serve as an RWE policy expert and scientific leader and be a strategic partner to VEO and Team Lilly to identify opportunities within IEG to optimize value of RWE to be included in label or label expansion.
  • Provide critical review for the study concept and design of innovative evidence studies, including but not limited pragmatic clinical trials, point of care studies, externally controlled trials etc., and review and approve study protocols intended for regulatory decision-making.
  • Experiment and be a champion of innovative evidence to drive and implement innovations and push the boundaries of what is possible with application of innovative RWE generation to support regulatory decision making and reimbursement.
  • Partner with VEO/COI team and CDDA (Clinical Design, Delivery and Analytics), as needed, to ensure on-strategy, on-time, and on-budget delivery of innovative evidence pilot studies.

Leadership in Innovative Trial Design Capabilities and Upskilling

  • Serve as a policy design expert to lead implementation of new capabilities in innovative trial design to deliver impactful RWE and results to optimize approval, accelerate patient access and transform healthcare delivery.
  • Support implementation and scaling up of new capabilities in innovative RWE trial design consistently by contributing to development of appropriate infrastructure, process, and automation tools to sustain the adoptions of innovative trial design in innovative evidence research.
  • Drive knowledge sharing and collaboration across the teams in innovative evidence design and delivery.
  • Effectively communicate and broaden the application of innovative trial design in RWE clinical research internally and externally.

Policy and External Partnership

  • Lead the development of policy initiatives and external partnerships with health care systems to co shape policies and external environment, and to enable the development and execution of innovative evidence research.
  • Anticipate and evaluate future market needs and identify trends for innovative evidence with innovative RWE trial design within pertinent therapeutic area and geography of interest.
  • Maintain awareness of significant developments in the field including current guidelines, methodologies, and applications of innovative RWE trial design in innovative evidence research, and other issues as appropriate for the position.

Minimum Qualification Requirements:

  • Advanced degree (MD, PharmD, Ph.D.) in a discipline relevant to clinical research, medical policy, epidemiology, HEOR and RWE with 10+ years of pharmaceutical industry related experience.

Additional Preferences:

  • Breadth of experience across HEOR/RWE methodologies and across study designs
  • Demonstrate leadership skills and influence stakeholders to resolve conflicts.
  • Demonstrate ability to inspire, motivate, and achieve alignment with diverse personnel even when they are not directly reporting into the organization.
  • Prior experience at regulatory agencies is preferred
  • Knowledge of drug development and commercialization, in particular knowledge of evidentiary standards for regulatory, formulary and health policy decision making and how that can be impacted throughout the drug development process.
  • Experience in designing or critical reviewing of innovative RWE studies for regulatory decision-making and clinical development.
  • Ability to network effectively with and use technical and non-technical skills to be a respected and influential cross-functionally.
  • Demonstrated leadership in establishing external partnership.

Additional Information:

  • Location is flexible in desired geography.
  • Domestic and international travel may be necessary.

Lilly currently anticipates that the base salary for this position could range from between $148,500 to $240,000 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.  

Eli 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.


As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). 

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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