BioNTech SE

Global HEOR Director

BioNTech SE

full-time

Posted on:

Location Type: Office

Location: Massachusetts • New Jersey • United States

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Job Level

Lead

Tech Stack

Delphi

About the role

  • 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) to optimize clinical development decisions across all stages of drug development
  • 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), ensuring alignment with labeling claims
  • 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 & Non HTA Markets like PICOS Simulation/Scoping, PICOS feasibility assessment and development JCA dossiers
  • Lead the development of early advice (EA) dossiers (Country level and JSC) and actively participate in discussion with relevant stakeholders on the value of the clinical program.
  • Stay at the forefront of industry trends and integrate emerging methodologies into evidence synthesis plans including the use of AI in SLR/ITCs/RWE and Global Value Evidence tool kit development
  • Collaborate with key opinion leaders, including medical experts, through structured engagements like advisory boards and Delphi panels
  • Develop pre-approval dossiers, launch models (CEA/BIA), tools, relevant Health Care Economic Information (HCEI) training materials to support US Account Management teams, Medical Science Liaisons, and field-based HEOR professionals
  • Support other HEOR team members by reviewing their evidence generation plans, publications and offering constructive- solution oriented feedback.
  • Mentor HEOR fellows and early-career team members while providing constructive feedback on evidence generation plans

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 COA Type C meetings and negotiating PRO label claims a plus
  • Proven track record of peer-reviewed publications showcasing HEOR expertise across multiple domains
  • Deep understanding of EU-HTA requirements including JSC/EA/JCA implementation alongside knowledge of global health technology assessment guidelines
  • Excellent communication skills with experience presenting HEOR research to payers/population health decision-makers.
Benefits
  • 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!
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
systematic literature reviewsindirect treatment comparisonscost-effectiveness analysesbudget impact analysesreal-world evidencepatient-reported outcomesepidemiology literature reviewsevidence synthesis strategieshealth economicsstudy design evaluation
Soft Skills
communication skillsmentoringcollaborationconstructive feedbackleadership
Certifications
MSPhDPharmDMD