Director- Health Economics and Outcomes Research- Clinical Outcomes Assessment

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 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 Health Economics and Outcomes Research (HEOR) 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 HEOR team and Team Lilly.

Clinical Outcomes Assessment (COA) involves scientific assessment of the patient voice throughout the lifecycle of drug development. Development and establishment of fitness-for-purpose clinical outcomes assessments (COAs), including Patient-Reported Outcomes (PROs), Clinician-Reported Outcomes (ClinROs), Performance Outcomes (PerfOs), and Observer-Reported Outcomes (ObsROs) is a key capability of COA. COA also encompasses the assessment of the patient voice as it relates to patient engagement, shared decision-making, patient activation, adherence, patient preferences, and other patient-centered assessments aimed at improving patient outcomes in real-world practice.

The Director sits within the HEOR Central team and is responsible for supporting and contributing to COA capability, collaborating with cross-HEOR teams focused on measuring and translating patient experience through rigorous scientific methods. The Director supports delivery of the overall COA strategy for HEOR and Lilly, contributing to the assessment of patient-centered outcomes across all phases of development. This involves providing scientific and strategic support to build capabilities for assessing and understanding the patient voice and contributing to the development of patient-focused product- and disease-state-specific strategies across the portfolio. This includes partnerships with cross-functional (e.g., regulatory) and HEOR therapeutic area scientists to support COA- and RWE-based label claims (FDA, EMA, and other geographies), and to contribute to benefit-risk patient-focused assessments in collaboration with Global Patient Safety (GPS).

In addition, the Director supports the HEOR evidence needs (e.g., RWE, COAs, early economic modeling, targeted literature research) for selected disease states and products in Lilly's early-phase portfolio, particularly in neuroscience, including contributing to and executing the HEOR research agenda. The Director will collaborate with early-phase cross-functional teams — including early clinical development, new product planning, value and access, and medical affairs — to support early-phase disease-state HEOR strategy and deliver HEOR projects.

Primary Responsibilities

Strategy Development and Execution (45%)

• Support sustained integration of HEOR and COA in early clinical development
• Contribute to COA capability building and support the COA operating model to execute Lilly's overall COA strategy
• Support development of disease-state and product-specific COA strategies with appropriate functional and cross-functional alignment
• Execute COA strategies in partnership with functional and cross-functional teams to optimize impact
• Contribute to collaboration models with cross-functional partners to measure patient voice of benefit-risk in drug development and regulatory decision making
• Support early-phase HEOR strategy development in selected disease areas, such as neuroscience
• Collaborate with HEOR colleagues to facilitate knowledge sharing across therapeutic areas, the HEOR Central team, and regional/affiliate teams

Research and Disclosure Oversight and Execution (30%)

• Execute work plans resulting in the development of relevant, reliable, and timely information for patients, regulators, clinicians, caregivers, and payers
• Create scientific materials submitted to regulators, ensuring consistent quality
• Publish research in peer-reviewed journals and present at scientific meetings
• Support effective packaging of scientific materials for patients and caregivers for dissemination and disclosure
• Develop effective working partnerships with project management teams to deliver planned work
• Communicate project status regularly and transparently to function leaders
• Contribute to the development and tracking of appropriate measures and metrics

Organizational Collaboration (15%)

• Support COA capability building across business units and contribute to innovative COA solutions for early clinical development and integrated evidence generation
• Collaborate with cross-functional teams to support early-phase HEOR strategy in selected neuroscience disease states
• Develop effective collaborative working relationships with key cross-functional colleagues
• Ensure compliance with appropriate internal and external standards and policies
• Support HEOR therapeutic areas and regional teams in the development of COA strategies and capabilities

External Engagement (10%)

• Support engagement with patient advocacy groups, regulators, external consortiums (e.g., Critical Path Institute Patient-Centered Evidence Consortium), disease-specific organizations, academic/government COA researchers, and other institutions
• Partner with TA teams, GPS, regulatory, and other key cross-functional colleagues on external initiatives and environment-shaping activities
• Monitor and understand the external environment and provide insights to inform future needs and priorities

Minimum Qualification Requirements

• Doctorate (PhD, MD, or Pharm D) with 10 years, OR master's degree with 15+ years of experience in creating, executing, and delivering outcomes strategies/projects in a discipline relevant to Health Outcomes

Additional Preferences

• Effective use of technical, leadership, and collaboration skills to be influential and respected across levels of the organization and cross-functionally
• Relevant drug development and/or commercialization experience within the pharmaceutical industry with solid knowledge of patient, regulator, and payer requirements
• Knowledge of the regulatory environment, including FDA Patient Focused Drug Development guidance, relevant guidances from other regulatory bodies, and evidentiary standards for Clinical Outcomes Assessment (e.g., PROs, ObsROs, ClinROs, PerfOs) label claims
• Demonstrated subject matter expertise and scientific contributions in COA development and strategy
• Demonstrated ability to contribute to and communicate scientific strategy to meet diverse, multi-stakeholder needs
• Experience supporting the creation or expansion of organizational capabilities
• Patient-focused qualitative and quantitative research experience across multiple therapeutic areas
• Network of relevant external scientific and regulatory contacts desirable
• Experience working with and through patient advocacy groups desirable
• Domestic and international travel will be required

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

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).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.

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