Director, Health Economics & Outcomes Research (HEOR)

1w1 week ago

BioNTech SE

Berkeley Heights, US · Full-time · $168,000 – $265,000

About this role

As the Global HEOR Director, you will be at the forefront of advancing BioNTech’s mission by driving impactful health economics and outcomes research strategies. You’ll shape value evidence-based approaches that contribute to global market access and reimbursement success. This ensures patients worldwide benefit from innovative therapies.

Your work will directly influence clinical development decisions, regulatory submissions, and payer communications and interactions. Leverage expertise in HEOR methodologies, real-world evidence, and cost-effectiveness analysis. Collaborate with cross-functional teams in a dynamic environment valuing scientific rigor and methodological advancements.

Develop global value evidence generation plans including systematic literature reviews, indirect treatment comparisons, and real-world evidence studies. Lead evidence synthesis for pharmaceutical launches and reimbursement dossiers across HTA and non-HTA markets. Engage with key opinion leaders through advisory boards and Delphi panels.

Mentor HEOR fellows and early-career team members while providing constructive feedback on evidence generation plans. Stay at the forefront of industry trends by integrating emerging methodologies like AI in SLR, ITCs, and RWE. Play a pivotal role in delivering transformative treatments to diverse populations.

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 regulations

Responsibilities

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)
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)
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 and non-HTA markets
Lead the development of early advice (EA) dossiers and participate in discussions with stakeholders on clinical program value
Collaborate with key opinion leaders through advisory boards and Delphi panels
Develop pre-approval dossiers, launch models (CEA/BIA), tools, and Health Care Economic Information (HCEI) training materials