Director, Global Value and Health Economics, Outcomes Research

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Formulate and implement the global and US payer evidence strategy for pipeline assets, spanning from early clinical development to regulatory approval and market launch.

• Oversee global payer evidence generation while acting as the US HEOR lead.

• Manage US pre-launch HEOR deliverables, tools for payer field enablement, and strategies for US market access evidence.

• Convert target product profiles and access goals into evidence generation initiatives, which include economic models, natural history studies, Global Value Dossiers, and US AMCP dossiers.

• Collaborate with Clinical Development, Biostatistics, and Clinical Operations to incorporate payer, formulary, and HTA requirements into Phase 2/3 trial designs.

• Enhance trial protocols through recommendations on comparators, inclusion/exclusion criteria, treatment-lines, and endpoints.

• Incorporate PROs, HRQoL, symptom burden scales, and HCRU instruments into pivotal trials.

• Develop evidence strategies for rare diseases using natural history data, biomarkers, and external or historical comparators.

• Design and lead health economic modeling strategies, including CEAs, BIMs, early conceptual models, and threshold analyses.

• Supervise the design, construction, and validation of adaptable global core economic models.

• Create US pre-launch evidence roadmaps and direct the development of AMCP PIE dossiers, burden-of-illness dossiers, and US budget impact models.

• Design economic models aimed at payers, evidence presentations, and population health tools.

• Lead HEOR workstreams within Launch Readiness Teams and manage global launch assets, such as GVDs and SLRs.

• Co-develop HTA strategies and analytic packages for EU/INT, including ITCs, NMAs, and country model adaptations.

• Plan and implement pre-launch real-world studies, chart reviews, registries, and burden-of-illness evaluations.

• Act as a GVHEOR stakeholder in IEGP governance and create payer evidence strategies.

• Establish scientific publication plans, co-author manuscripts, and present findings at major conferences.

• Mentor junior HEOR scientists, post-doctoral fellows, and colleagues across the matrix.

⛳️ Requirements

• A Master’s degree (MSc, MS, MPH, PhD) in Health Economics, Outcomes Research, Pharmacoeconomics, or a closely related quantitative field is required.

• A minimum of 7–10 years of experience in HEOR, Global Value, or Health Economics in the biopharmaceutical industry or a leading HEOR consulting firm.

• A proven history of collaboration with Clinical Development, Commercial Development, and Biostatistics teams to influence Phase 2/3 trial design, comparator selection, resource use collection, and PRO/HRQoL endpoint choices.

• Strong understanding of the US managed care and market access landscape, including commercial payers, Medicare Advantage, Medicare Part D/B, Medicaid, and PBMs.

• In-depth knowledge of global HTA frameworks, such as EU HTA Regulation/JCA, NICE, G-BA, PBAC, and CADTH.

• Demonstrated ability to lead HEOR launch-readiness workstreams and deliver GVDs, AMCP PIE dossiers, and global ITCs/NMAs within stringent regulatory filing timelines.

• Comprehensive understanding of the evidentiary challenges in rare disease drug development, including natural history studies, registries, translation from surrogate to clinical endpoints, external control arms, and specialized HTA pathways.

• A proven capacity to establish strategic vision and execute as well as quality-check complex technical models, statistical analysis plans, and dossier sections.

• Successful collaboration with regional HEOR teams, particularly in the EU/INT region.

• Ability to influence cross-functional peers and senior leadership across Clinical Development, Medical Affairs, Market Access, and Commercial sectors without formal authority.

• Excellent written and verbal communication skills, with a record of HEOR and clinical publications in respected medical and economic journals or HTA achievements.

• Direct experience in leading HEOR strategy and deliverables for pipeline assets, including early Phase 2/3 clinical trial protocol integration, endpoint development, and global launch readiness.

• Experience managing regional trade-offs concerning evidence needs during Phase 2/3 protocol development.

• Served as launch lead for at least two assets as the US HEOR lead or as a country-level HTA lead.

• Practical experience in designing, overseeing, or adapting health economic models.

• Collaborated with regional HEOR teams to provide evidence packages supporting HTA readiness and submissions.

🏝️ Benefits

• Discretionary annual cash bonus or incentive compensation.

• Discretionary equity grants.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401k retirement savings plan.

• Flexible paid vacation.