Associate Director, HEOR (Classical Hematology)
Regeneron
5 hours ago
On-site
Sleepy Hollow, NY
Market Access
Associate Director (HEOR)
Responsibilities:
- Develop and implement global HEOR strategies and programs for the portfolio throughout the product lifecycle to support clinical development, regulatory needs, and optimal market access.
- Collaborate with business partners to develop and support product value propositions to optimize future patient access.
- Identify HEOR evidence requirements and gaps; design, conduct, and deliver HEOR studies and tools for relative value demonstration and product differentiation.
- Leverage real-world data (RWD) analytic tools and collaborate with HEOR RWDnA and Epidemiology teams to generate insights for development programs and key business questions.
- Co-lead regulatory-grade real world evidence (RWE) studies and provide education on emerging RWE opportunities.
- Conduct and communicate epidemiology and pharmacoepidemiology analyses in support of development and regulatory goals.
- Provide input on patient population, comparators, and endpoints in clinical trials to demonstrate incremental value over standard of care.
- Develop and implement Clinical Outcomes Assessment (COA) measurement strategies and plans for labeling, patient access, and differentiation; develop/validate COA endpoints, analyze/report data, and produce COA evidence dossiers for regulatory submissions.
- Report, publish, and disseminate HEOR data and study results in compliance with company, industry, and regulatory requirements.
Qualifications:
- Advanced graduate degree (Ph.D., MS, MD, PharmD, or B.Pharm with a Master’s degree) in an HEOR-related field (e.g., pharmacoepidemiology, epidemiology, healthcare/data analytics, health economics, health services research, public health).
- 4+ years with PhD or 6+ years with MS in HEOR.
- At least 3 years of life science company or healthcare consulting experience (plus).
- Strong technical expertise in design and conduct of HEOR studies and models.
- Solid understanding of regulatory considerations (e.g., FDA, EMA).
- Experience designing and implementing patient experience data in clinical trials, including instrument selection, analysis, and reporting.
Preferred/Personal fit (from posting):
- Impact patient lives; enjoy a rapid response environment; opportunity to present to senior leaders; part of a growing high-performing team.
Location/Work requirements:
- Sleepy Hollow, NY; onsite 4 days/week (no remote option). Relocation benefits may be available if eligible.
Benefits (explicitly mentioned):
- Health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave).
Application instructions:
- “Apply now.”
Responsibilities:
- Develop and implement global HEOR strategies and programs for the portfolio throughout the product lifecycle to support clinical development, regulatory needs, and optimal market access.
- Collaborate with business partners to develop and support product value propositions to optimize future patient access.
- Identify HEOR evidence requirements and gaps; design, conduct, and deliver HEOR studies and tools for relative value demonstration and product differentiation.
- Leverage real-world data (RWD) analytic tools and collaborate with HEOR RWDnA and Epidemiology teams to generate insights for development programs and key business questions.
- Co-lead regulatory-grade real world evidence (RWE) studies and provide education on emerging RWE opportunities.
- Conduct and communicate epidemiology and pharmacoepidemiology analyses in support of development and regulatory goals.
- Provide input on patient population, comparators, and endpoints in clinical trials to demonstrate incremental value over standard of care.
- Develop and implement Clinical Outcomes Assessment (COA) measurement strategies and plans for labeling, patient access, and differentiation; develop/validate COA endpoints, analyze/report data, and produce COA evidence dossiers for regulatory submissions.
- Report, publish, and disseminate HEOR data and study results in compliance with company, industry, and regulatory requirements.
Qualifications:
- Advanced graduate degree (Ph.D., MS, MD, PharmD, or B.Pharm with a Master’s degree) in an HEOR-related field (e.g., pharmacoepidemiology, epidemiology, healthcare/data analytics, health economics, health services research, public health).
- 4+ years with PhD or 6+ years with MS in HEOR.
- At least 3 years of life science company or healthcare consulting experience (plus).
- Strong technical expertise in design and conduct of HEOR studies and models.
- Solid understanding of regulatory considerations (e.g., FDA, EMA).
- Experience designing and implementing patient experience data in clinical trials, including instrument selection, analysis, and reporting.
Preferred/Personal fit (from posting):
- Impact patient lives; enjoy a rapid response environment; opportunity to present to senior leaders; part of a growing high-performing team.
Location/Work requirements:
- Sleepy Hollow, NY; onsite 4 days/week (no remote option). Relocation benefits may be available if eligible.
Benefits (explicitly mentioned):
- Health and wellness programs (medical, dental, vision, life, disability), fitness centers, 401(k) match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave).
Application instructions:
- “Apply now.”