New Jersey, US   |   full time   |   Job ID: 9684 

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.

Requirements:

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 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, 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.
• 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 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.

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
• 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.
 

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.

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 BioNTech-Recruiter.