Director- Health Economics and Outcomes Research- Clinical Outcomes Assessment

Lilly•Indianapolis, IN

About The Position

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.

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

Nice To Haves

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

Responsibilities

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
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
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
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

Benefits

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
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).

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