Director – Health Economics and Outcomes Research, Clinical Outcomes Assessment

Role Overview

• 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

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
• 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.

Benefits

• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)