Director, Health Economics & Outcomes Research

New Jersey, US   |   full time   |   Job ID: 8593 

Responsibilities:

• 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 type of HEOR research
  • Leading/supporting relevant Real-World Evidence (RWE) activities (claims database, registries, EMR/EHR) to meet asset-specific evidence needs 
  • Conducting global epidemiology targeted literature reviews including to inform multi-regional clinical trial site selection and recruitment
  • Communicating findings in relevant regulatory-grade documents (i.e., FDA briefing books, US Diversity Action Plan, Pediatric Investigation Plan)
• Stay abreast of industry trends and emerging evidence synthesis methodologies, ensuring that the organization remains at the forefront of methodological advancements.
• Draft and execute early evidence synthesis plan (eSLR/eNMA/eCEA) to inform clinical development decisions for the molecules at the early stages of drug development.
• Oversee the development and implementation of robust evidence synthesis plans to support global launches and reimbursement dossiers in the key HTA and non-HTA markets.
• Provide thought leadership in the areas of evidence synthesis as a subject matter expert within the HEOR team.
• Collaborate and elicit input from key opinion leaders including medical experts, including in structured settings (e.g., Delphi panel, advisory boards).
• Support other HEOR team members by reviewing their evidence synthesis plan and offering constructive-solution oriented feedback.
• Advance BioNTech’s US/Global Pharmaceutical launch activities, specifically:
• • Pre-Approval Dossier and Pre-Approval Information Exchange with population health decision makers (FDA Guidance)
  • Launch models (CEA/BIA) and tools development
• Provide training and develop relevant materials to support field teams-US Market Access Account Management/ Medical Science Liaisons and HEOR Field based teams current and relevant HCEI developed by the organization.
• Serve as subject matter expert for cross-functional teams in the area of HEOR.
• Mentor HEOR fellow(s) and other junior HEOR team members.

Qualifications:  

Education 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 3-5 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 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 type 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 type of HEOR research.
• Strong knowledge on development, psychometric evaluation and selection of PROs preferred.
  • Experience with eCOA implementation preferred, including but not limited to eCOA vendor identification, qualification and technical supervision Assist clin ops team members in securing licenses and commissioning translations/adaptations for COA instruments in a timely manner.
  • Experience with developing meeting requests/briefing books to support FDA COA Type C meetings.
  • Regulatory understanding and experience in negotiating PRO label claims is strongly 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 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)
• Deep knowledge of scientific research and reporting standards (e.g., ISPOR CHEERs), ethical guidelines (i.e., familiarity with IRB-approval requirements), and industry regulations.
• Excellent communication skills, with experience presenting HEOR research to payers and/or population health decision-makers.
• Good working knowledge of health care systems and health technology assessment guidelines and processes in relevant countries.

Your Benefits:

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

…and more! More details to be shared.
 

Berkeley Heights is New Jersey's growing hub within the life sciences industry and has already demonstrated the state’s commitment to innovation, collaboration, and excellence within the field. New Jersey's integrated approach to biotechnology and pharmaceuticals harmonizes academic rigor, industrial capability, and government support to create thriving conditions for a growing ecosystem. Cultivating an environment that seamlessly integrates cutting-edge research, robust manufacturing capabilities, and a dynamic business landscape, New Jersey has become a powerhouse in pharmaceuticals, biotechnology, and medical technology. As this region of New Jersey continues to develop, it stands ready to shape the future of medical science and technology, driving progress and improving health outcomes worldwide.

Apply now - We look forward to your application!

Apply for our New Jersey, US location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your Recruiter.