Director, Health Economics & Outcome Research

Role Summary

Director, Health Economics & Outcome Research. Location: New Jersey, US. Full time.

Responsibilities

• Draft and execute value evidence generation plans for SLR, NMA/ITC, CEA/BIA, RWE and PRO SAP to inform clinical development decisions and value evidence for the molecules across all stages of drug development.
• Conduct global epidemiology targeted literature reviews to inform multi-regional clinical trial site selection and recruitment.
• Stay abreast of industry trends and emerging evidence synthesis methodologies, ensuring the organization remains at the forefront of methodological advancements.
• Collaborate and elicit input from key opinion leaders including medical experts, including in structured settings (e.g., Delphi panel, advisory boards).
• Advise and implement the FDA Guidance and other relevant PRO and PFDD developments where applicable in the clinical programs.
• Develop and communicate findings in regulatory-grade documents (e.g., FDA briefing books, Pediatric Investigation Plan).
• Oversee the development and implementation of robust evidence synthesis plans to support global launches and reimbursement dossiers in key HTA and non-HTA markets.
• Advance BioNTech’s US/Global Pharmaceutical launch activities, specifically:
  • Pre-Approval Dossier and Pre-Approval Information Exchange with population health decision makers
  • Launch models (CEA/BIA) and associated tools and dossier development
  • Provide training and develop Health Care Economic Information (HCEI) materials to support field teams
• Support other HEOR team members by reviewing their evidence generation plans and providing constructive feedback.
• Serve as subject matter expert for cross-functional teams in HEOR.
• Mentor HEOR fellow(s) and early career HEOR team members.

Qualifications

• MS required; Doctoral degree (PhD/PharmD/MD) preferred in a related field with HEOR experience (fields include Public Health-Health Policy & Management, Health Services Research, Epidemiology, Outcomes Research, Health Economics, Econometrics, Psychometrics, Statistics/Biostatistics, Pharmacoeconomics).
• At least 5 years of relevant experience in related field, or a Master’s degree with at least 10 years of relevant experience.

Experience

• Strong understanding of Systematic Literature Reviews (SLR) methodology and Indirect Treatment Comparisons (ITC, including network meta-analysis), with ability to critically evaluate/improve study design and data sources.
• Deep understanding of Global Cost Effectiveness Analysis/Budget Impact Analysis (CEA/BIA) models (US and Ex-US) and ability to critically evaluate/improve study design and data sources.
• Solid understanding of RWE research designs (e.g., US sources like Komodo, Optum, MarketScan; Ex-US sources) and ability to critically evaluate/improve study design and data sources.
• Experience with eCOA implementation (preferred).
• Experience with developing meeting requests/briefing books to support FDA COA Type C meetings; regulatory understanding and negotiating PRO label claims (preferred).
• Track record of peer-reviewed publications demonstrating HEOR expertise across RWE, CEA/BIA, PRO development/analytics, and SLR/NMA/ITC.
• Knowledge of compliant HEOR tools for US population health decision makers/HCEI.
• Understanding of EU-HTA requirements including JCA implementation.
• Good working knowledge of health care systems and HTA guidelines in relevant countries.
• Excellent communication skills with experience presenting HEOR research to payers and population health decision-makers.

Education

• MS required; PhD/PharmD/MD preferred in related field.

Additional Requirements

• Travel: Not specified in source.