Global HEOR Director
BioNTech SE
5 months ago
Remote friendly (Berkeley Heights, NJ)
United States
Market Access
Your contribution:
- Develop and execute Global value evidence generation plans for SLR, ITC, CEA, BIA, RWE, and PRO to optimize clinical development decisions.
- Conduct global epidemiology literature reviews to inform multi-regional clinical trial site selection and recruitment.
- Provide guidance on FDA regulations for PROs and PFDD, ensuring alignment with labeling claims.
- Prepare regulatory-grade documents (e.g., FDA/Global Regulatory briefing books) for PRO endpoint implementation, epidemiology, and pediatric investigation plans.
- Lead evidence synthesis strategies to support global pharmaceutical launches and reimbursement dossiers across HTA and Non-HTA markets (e.g., PICOS simulation/scoping, feasibility assessment, development JCA dossiers).
- Develop early advice (EA) dossiers (country level and JSC); participate in stakeholder discussions and integrate emerging methods (including AI in SLR/ITCs/RWE).
- Collaborate with key opinion leaders via advisory boards and Delphi panels.
- Develop pre-approval dossiers, launch models (CEA/BIA), tools, and HCEI training materials for US Account Management, Medical Science Liaisons, and field-based HEOR professionals.
- Review other HEOR team members’ evidence generation plans/publications and provide constructive feedback.
- Mentor HEOR fellows and early-career team members.
A good match:
- MS required; PhD/PharmD/MD preferred in Public Health, Epidemiology, Health Economics, or related fields.
- At least 5 years relevant HEOR experience (or 10 years with MS) across SLR, ITC/NMA/MAIC/STC, CEA/BIA, RWE designs, and PRO analytics.
- Expertise in US/Ex-US real-world data sources (e.g., Komodo, Optum, Medicare RIF).
- eCOA implementation experience preferred; familiarity with FDA COA Type C meetings and negotiating PRO label claims a plus.
- Peer-reviewed publication track record.
- Deep understanding of EU-HTA requirements (JSC/EA/JCA) and global HTA guidelines.
- Excellent communication skills presenting HEOR research to payers/population health decision-makers.
Your Benefits:
- Medical, Dental and Vision Insurance; Life, AD&D, Critical Illness Insurance.
- Pre-tax HSA & FSA, DCRA Spending Accounts; Employee Assistance & Concierge Program (EAP).
- Parental and Childbirth Leave & Family Planning Assistance; Sitterstream.
- Paid Time Off (Vacation, Sick, Bereavement, Holidays, Year-End U.S. Shutdown).
- 401(K) plan with company match; tuition reimbursement; professional development.
- Commuting allowance/subsidized parking; discounted insurance (Home, Auto & Pet).
Apply now:
- Apply for the Cambridge, US; New Jersey, US location and submit documents via the online application form.
- Develop and execute Global value evidence generation plans for SLR, ITC, CEA, BIA, RWE, and PRO to optimize clinical development decisions.
- Conduct global epidemiology literature reviews to inform multi-regional clinical trial site selection and recruitment.
- Provide guidance on FDA regulations for PROs and PFDD, ensuring alignment with labeling claims.
- Prepare regulatory-grade documents (e.g., FDA/Global Regulatory briefing books) for PRO endpoint implementation, epidemiology, and pediatric investigation plans.
- Lead evidence synthesis strategies to support global pharmaceutical launches and reimbursement dossiers across HTA and Non-HTA markets (e.g., PICOS simulation/scoping, feasibility assessment, development JCA dossiers).
- Develop early advice (EA) dossiers (country level and JSC); participate in stakeholder discussions and integrate emerging methods (including AI in SLR/ITCs/RWE).
- Collaborate with key opinion leaders via advisory boards and Delphi panels.
- Develop pre-approval dossiers, launch models (CEA/BIA), tools, and HCEI training materials for US Account Management, Medical Science Liaisons, and field-based HEOR professionals.
- Review other HEOR team members’ evidence generation plans/publications and provide constructive feedback.
- Mentor HEOR fellows and early-career team members.
A good match:
- MS required; PhD/PharmD/MD preferred in Public Health, Epidemiology, Health Economics, or related fields.
- At least 5 years relevant HEOR experience (or 10 years with MS) across SLR, ITC/NMA/MAIC/STC, CEA/BIA, RWE designs, and PRO analytics.
- Expertise in US/Ex-US real-world data sources (e.g., Komodo, Optum, Medicare RIF).
- eCOA implementation experience preferred; familiarity with FDA COA Type C meetings and negotiating PRO label claims a plus.
- Peer-reviewed publication track record.
- Deep understanding of EU-HTA requirements (JSC/EA/JCA) and global HTA guidelines.
- Excellent communication skills presenting HEOR research to payers/population health decision-makers.
Your Benefits:
- Medical, Dental and Vision Insurance; Life, AD&D, Critical Illness Insurance.
- Pre-tax HSA & FSA, DCRA Spending Accounts; Employee Assistance & Concierge Program (EAP).
- Parental and Childbirth Leave & Family Planning Assistance; Sitterstream.
- Paid Time Off (Vacation, Sick, Bereavement, Holidays, Year-End U.S. Shutdown).
- 401(K) plan with company match; tuition reimbursement; professional development.
- Commuting allowance/subsidized parking; discounted insurance (Home, Auto & Pet).
Apply now:
- Apply for the Cambridge, US; New Jersey, US location and submit documents via the online application form.