Director, Health Economics & Outcome Research

Role Summary

Director, Health Economics & Outcome Research based in New Jersey, responsible for leading value evidence generation programs, advising on regulatory PRO approaches, and supporting global launches and HTA submissions across the product portfolio.

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 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 for multi-regional trials, Pediatric Investigation Plan).
• Oversee the development and implementation of robust evidence synthesis plans to support global launches and reimbursement dossiers in key HTA (e.g., JCA dossiers) 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 dossier development; Provide training and develop HCEI materials to support field teams.
• Support other HEOR team members by reviewing their evidence generation plans, publication reviews and offering constructive feedback.
• Serve as subject matter expert for cross-functional teams in HEOR.
• Mentor HEOR fellow(s) and early career HEOR team members.

Qualifications

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

Experience

• A solid understanding of Systematic Literature Reviews (SLR) methodology, Indirect Treatment Comparisons (ITC) including network meta-analysis (NMA) and matching-adjusted indirect comparisons (MAIC/STC).
• Deep understanding of Global Cost Effectiveness Analysis/Budget Impact Analysis (CEA/BIA) models (US and Ex-US) with ability to evaluate study design and data sources.
• Solid understanding of Real-World Evidence (RWE) research designs (e.g., US: Komodo, Optum, MarketScan, Pharmetrics Plus, Medicare RIF; Ex-US: NCRAS, SNDS, other EU data sources).
• Experience with eCOA implementation preferred (vendor identification, qualification, and technical supervision).
• Experience developing meeting requests/briefing books to support FDA COA Type C meetings; regulatory understanding and experience in negotiating PRO label claims is preferred.
• Track record of peer-reviewed publications in HEOR across RWE, CEA/BIA, PRO development & analytics, SLR/NMA/ITC.
• Knowledge of compliant HEOR tools for US population health decision makers/HCEI.
• Understanding of current EU-HTA requirements including recent JCA implementation.
• Good working knowledge of health care systems and HTA guidelines and processes in relevant countries.
• Excellent communication skills with experience presenting HEOR research to payers and population health decision-makers.

Skills

• HEOR strategy and project leadership
• Evidence synthesis and economic modeling
• Regulatory affairs and health technology assessment
• Data interpretation and scientific communication
• Mentorship and cross-functional collaboration

Education

• MS degree required; PhD/PharmD/MD preferred in a related field as listed above.