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BioNTech SE · 3 days ago

Director, Health Economics & Outcome Research

Cambridge, MA

Full-time

Onsite

Lead/Staff, Director/Executive

$210K/yr - $240K/yr

5+ years exp

BioNTech SE is a leading biopharmaceutical company focused on developing innovative therapies. They are seeking a Director of Health Economics & Outcome Research to draft and execute value evidence generation plans, conduct literature reviews, and collaborate with key opinion leaders to inform clinical development decisions and support global launches.

Health Care

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

Conducting global epidemiology targeted literature reviews including 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 Patient-Focused Drug Development (PFDD) developments where applicable in the clinical programs

Develop and communicate findings in relevant 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 the 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

Qualification

Health EconomicsOutcomes ResearchReal-World EvidenceCost Effectiveness AnalysisSystematic Literature ReviewsBudget Impact AnalysisECOA ImplementationFDA Regulatory KnowledgeCommunicationMentoring Skills

Required

MS required, Doctoral degree (PhD/PharmD/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

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, MarketScan, 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

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 health decision makers/Health Care Economic Information (HCEI)

Understanding of current EU-HTA requirements including the recent JCA implementation

Good working knowledge of health care systems and health technology assessment guidelines and processes in relevant countries

Excellent communication skills, with experience presenting HEOR research to payers and/or population health decision-makers

Preferred

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