Director, Health Economics & Outcome Research

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New Jersey, US | full time | Job

• 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 that 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 such as Guidance for Industry Patient-Reported Outcome Measures:
  Use in Medical Product Development to Support Labeling Claims and other relevant PRO and PFDD developments where applicable in the clinical programs.
• Develop and communicate findings in regulatory-grade documents (i.e., FDA briefing books - multi-regional clinical trial/DAP, 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 associated tools and dossier development
  • Provide training and develop relevant Health Care Economic Information (HCEI) materials to support field teams-US Account Management, Medical Science Liaisons and HEOR Field based
• Support other HEOR team members by reviewing their evidence generation plans, publication review and offering constructive, solution-oriented feedback.
• Serve as subject matter expert for cross-functional teams in HEOR.
• Mentor HEOR fellow(s) and early career HEOR team members.

Education Required

• MS required, Doctoral degree (PhD/Pharm
  
  D/MD) preferred in related field and experience conducting HEOR (Related fields include Public Health-Health Policy & Management/Health Services Research/Epidemiology/Outcomes Research/Health Economics, Economics/Econometrics, Psychometrics, Statistics/Biostatistics, Pharmacoeconomics/Pharmacy Administration)
• At least 5 years of relevant experience in related field OR a Master’s degree in related field, and at least 10 years of such relevant experience

Experience Required

• A solid understanding of Systematic Literature Reviews (SLR) methodology, Indirect Treatment Comparisons (ITC, including network meta-analysis [NMA], matching adjusted indirect comparisons [e.g.: MAIC/STC]) with ability to critically evaluate-improve study design and data sources used across various types of HEOR research
• A deep understanding of Global Cost Effectiveness Analysis/Budget Impact Analysis (CEA/BIA) models-US and Ex-US, with ability to critically evaluate-improve study design and data sources used across various types of HEOR research.
• A solid understanding of RWE research designs (US-Komodo, Optum, Market Scan, Pharmetrics Plus, and/or Medicare RIF, Ex-US: NCRAS, SNDS, Other EU real world data sources and registries) with ability to critically evaluate-improve study design and data sources used across various types of HEOR research.
• Experience with eCOA implementation preferred, including but not limited to eCOA vendor identification, qualification and technical supervision
• Experience with developing meeting requests/briefing books to support FDA COA Type C meetings. Regulatory understanding and experience in negotiating PRO label claims is preferred.
• A track record of peer-reviewed scientific publications demonstrating expertise in HEOR across Real-World Evidence, Cost-Effectiveness Analysis/Budget Impact Analysis models, PRO development & analytics and SLR/NMA/ITC.
• Successfully developed/has a deep knowledge of/exposure to compliant HEOR tools for US population…