Director, Health Economics – Outcomes Research (HEOR)

Role Overview

• Develop and execute Global value evidence generation plans for systematic literature reviews (SLR), indirect treatment comparisons (ITC), cost-effectiveness analyses (CEA), budget impact analyses (BIA), real-world evidence (RWE), and patient-reported outcomes (PRO) to optimize clinical development decisions across all stages of drug development
• Conduct global epidemiology literature reviews to inform multi-regional clinical trial site selection and recruitment strategies
• Provide guidance on FDA regulations related to patient-reported outcomes (PROs) and patient-focused drug development (PFDD), ensuring alignment with labeling claims
• Prepare regulatory-grade documents such as FDA/Global Regulatory briefing books for PRO Endpoint implementation, epidemiology, and pediatric investigation plans
• Lead the implementation of robust evidence synthesis strategies to support global pharmaceutical launches and reimbursement dossiers across HTA markets & Non HTA Markets like PICOS Simulation/Scoping, PICOS feasibility assessment and development JCA dossiers
• Lead the development of early advice (EA) dossiers (Country level and JSC) and actively participate in discussion with relevant stakeholders on the value of the clinical program
• Stay at the forefront of industry trends and integrate emerging methodologies into evidence synthesis plans including the use of AI in SLR/ITCs/ RWE and Global Value Evidence tool kit development
• Collaborate with key opinion leaders, including medical experts, through structured engagements like advisory boards and Delphi panels
• Develop pre-approval dossiers, launch models (CEA/BIA), tools, relevant Health Care Economic Information (HCEI) training materials to support US Account Management teams, Medical Science Liaisons, and field-based HEOR professionals
• Support other HEOR team members by reviewing their evidence generation plans, publications and offering constructive
• solution oriented feedback
• Mentor HEOR fellows and early-career team members while providing constructive feedback on evidence generation plans

Requirements

• MS required; Doctoral degree (PhD/PharmD/MD) preferred in Public Health, Epidemiology, Health Economics, or related fields with significant experience conducting HEOR research
• At least 5 years of relevant experience (or 10 years with MS degree) conducting HEOR research across methodologies such as SLR, ITC/NMA/MAIC/STC, CEA/BIA models, RWE designs, and PRO analytics
• Expertise in US/Ex-US real-world data sources (e.g., Komodo, Optum, Medicare RIF) with proficiency in study design evaluation and improvement
• Experience with eCOA implementation preferred; familiarity with FDA COA Type C meetings and negotiating PRO label claims a plus
• Proven track record of peer-reviewed publications showcasing HEOR expertise across multiple domains
• Deep understanding of EU-HTA requirements including JSC/EA/JCA implementation alongside knowledge of global health technology assessment guidelines
• Excellent communication skills with experience presenting HEOR research to payers/population health decision-makers

Tech Stack

• Delphi

Benefits

• Competitive remuneration packages
• Benefits in support of our diverse employee base that may include health insurance, retirement plans, paid time off, flexible working arrangements, professional development, bonuses, stock options, equipment allowances, wellness programs