Research Director Jobs in Pennsylvania

Brief Description:

The Director, Global Value and HEOR is a high-visibility strategic and execution-oriented leadership role responsible for defining and driving the global and US payer evidence strategy for pipeline assets from early clinical development (Phase 2/3) through global regulatory approval and launch.

Operating with a dual mandate, the Director leads global payer evidence generation while directly serving as the US HEOR lead, spearheading all US pre-launch HEOR deliverables, payer field enablement tools, and US market access evidence strategies. The Director acts as the vital strategic evidence engine that validates and substantiates the value story developed by Global and US Market Access teams. As a core stakeholder in the Integrated Evidence Generation Plan (IEGP) governance, this role translates target product profiles (TPPs) and access ambitions into methodologically sound evidence generation programs—including early conceptual and global core health economic models, real-world natural history studies, Global Value Dossiers (GVDs), and US AMCP dossiers.

The Director serves as the primary conduit to Clinical Development, ensuring global payer, US health plan, and HTA requirements—particularly those unique to rare diseases, such as limited patient cohorts, single-arm designs, surrogate endpoints, and data uncertainty—are proactively integrated into Phase 2 and pivotal Phase 3 study designs. Working in close partnership with regional teams, the Director collaborates directly with the dedicated EU/INT HEOR team to co-develop HTA evidence strategies and deliver robust analytical packages (e.g., indirect comparisons, network meta-analyses, and adaptable core models) for European HTA bodies and the EU Joint Clinical Assessment (JCA).

The post holder not only needs to be an excellent strategist, but also be a deep expert delivering projects with vendors, and sometimes doing models etc in house rather than outsourcing them. An ability to create a virtuous circle whereby they use their depth of knowledge to inform strategy, and their knowledge of strategy to inform the evidence that we generate is key to long term success.

Essential Functions/Responsibilities

1. Phase 2/3 Clinical Trial & Early Evidence Integration

• Early Payer & Access Evidence Integration: Partner proactively with Clinical Development Leads, Biostatistics, and Clinical Operations from Phase 2 planning through Phase 3 protocol freeze to ensure global payer, US formulary, and HTA evidence requirements are systematically incorporated into trial designs.

• Trial Protocol Optimization: Advocate for value-enhancing clinical protocol elements, including clinically meaningful active or standard-of-care comparators, optimized inclusion/exclusion criteria, relevant treatment lines, and endpoints recognized by health technology assessors and US commercial/public payers.

• Patient-Centered & Economic Endpoints: Collaborate closely with Patient-Centered Outcomes (PCO) and Clinical teams to integrate validated Patient-Reported Outcomes (PROs), health-related quality of life (HRQoL), symptom burden scales, and healthcare resource utilization (HCRU) instruments into pivotal clinical trials.

• Rare Disease Pipeline Evidence Strategy: For orphan and rare disease assets, design innovative approaches to address clinical trial limitations (e.g., small patient sample sizes, absence of randomized control arms, or surrogate primary endpoints) by embedding natural history data, disease progression biomarkers, and external/historical comparator cohorts into early program strategy.

2. Advanced Health Economic Modeling Strategy & Execution

• Early Modeling Strategy: Architect and lead innovative, fit-for-purpose health economic modeling strategies starting in early development (early conceptual economic models, headroom/threshold analyses, cost-effectiveness analyses [CEA], and budget impact models [BIM]).

• Navigating High Uncertainty & Orphan Paradigms: creative, technically sophisticated modeling methodologies to resolve data gaps, small patient cohorts, immature progression/survival data, and clinical trial uncertainty typical of rare disease and specialty pipeline assets (e.g., dynamic Markov models, Bayesian extrapolation, structured expert elicitation, and extensive probabilistic sensitivity analyses).

• Global Core Model Architecture: Direct the design, build, and validation of transparent, fully executable global core economic models engineered for dual utility: adaptable by the EU/INT HEOR team for national HTA dossiers and modifiable for US commercial and public payer contexts.

3. Dual Remit: Dedicated US Pre-Launch HEOR Leadership

• US Pre-Launch HEOR Strategy & Execution: Serve as the designated US HEOR lead across assigned pipeline assets, developing and executing the US-specific pre-launch evidence generation roadmap in close coordination with US Market Access and US Medical Affairs.

• US Pre-Approval Dossiers & Formulary Tools: Lead the authoring, development, and timely completion of the US AMCP Pre-Approval Information Exchange (PIE) dossier, unbranded burden-of-illness dossiers, and US budget impact models tailored to commercial health plans, Medicare Part D/Part B, and state Medicaid programs.

• US Payer Field Team Enablement: Partner with the US Payer Value and Outcomes team to design compliant, customer-facing interactive economic models, evidence slide decks, and population health tools.

• US Policy, IRA & ICER Readiness: Anticipate US policy and value assessment impacts—including early readiness for Institute for Clinical and Economic Review (ICER) evaluations and strategic evidence planning under the Inflation Reduction Act (IRA) and CMS price negotiations.

4. Launch Readiness & Core Deliverable Execution

• Launch Readiness Workstreams: Lead HEOR workstreams within cross-functional Launch Readiness Teams (LRT), ensuring all economic, clinical, and humanistic evidence assets are fully validated, peer-reviewed, and ready for Day 1 commercial and regulatory milestones.

• Global Core Evidence Assets: Personally oversee and drive the creation of foundational global launch assets, including Global Value Dossiers (GVDs), systematic literature reviews (SLRs), and early value communication tools.

• Collaborative EU/INT HTA Evidence Support: Partner with the dedicated EU/INT HEOR team to co-develop HTA evidence strategies and deliver foundational analytic packages (indirect treatment comparisons [ITCs], network meta-analyses [NMAs], and country model adaptations) for the EU Joint Clinical Assessment (JCA), NICE, G-BA, CADTH, and other international bodies.

• Pre-Launch Observational Research & RWE: Collaborate with RWE and epidemiology teams to design and execute pre-launch real-world studies, retrospective chart reviews, disease registries, and burden-of-illness evaluations using US and international data sources to quantify unmet need and define baseline standard of care prior to approval.

5. Cross-Functional Partnership & Governance

• Substantiating the Value Story: Formulate and execute the targeted payer evidence strategy required to substantiate, quantify, and defend the product value story developed by the Market Access team.

• Integrated Evidence Generation Plan (IEGP): Serve as a core GVHEOR stakeholder in IEGP governance, ensuring pipeline HEOR and payer evidentiary priorities are prioritized, appropriately funded, and executed on schedule.

• Cross-Functional Collaboration: Act as the trusted HEOR authority across Clinical Development, Market Access, Medical Affairs, Regulatory Affairs, and Commercial Brand teams.

• Scientific Publications & Congress Dissemination: Develop and execute the pre-launch scientific publication plan; draft and co-author high-impact manuscripts in peer-reviewed journals and present novel methodologies and study results at leading congresses (e.g., ISPOR, AMCP, and disease-specific medical congresses).

• Talent Mentorship & Matrix Leadership: Mentor junior HEOR scientists, post-doctoral fellows, and matrix colleagues, fostering technical excellence and strategic acumen across the broader organization.

Required Knowledge, Skills, and Abilities

• Health Economic Modeling Mastery: Deep technical and conceptual expertise in health economic modeling (Markov state-transition, partitioned survival, microsimulation, and decision-tree models). Demonstrated ability to construct creative, defensible economic models in data-sparse pipeline environments and rare diseases.

• Pipeline & Trial Interface Experience: Proven track record of collaborating directly with Clinical Development, Commercial Development and Biostatistics teams to influence Phase 2/3 trial design, comparator choice, trial-based resource use collection, and PRO/HRQoL endpoint selection.

• Dual Global and US Pre-Launch Acumen: Strong familiarity with the US managed care and market access landscape (commercial payers, Medicare Advantage, Medicare Part D/B, Medicaid, PBMs) coupled with deep understanding of global HTA frameworks (e.g., EU HTA Regulation / JCA, NICE, G-BA, PBAC, CADTH).

• Launch Preparation Excellence: Demonstrated capability to lead HEOR launch-readiness workstreams, coordinate Day 1 access deliverables, and deliver comprehensive GVDs, AMCP PIE dossiers, and global ITCs/NMAs under tight regulatory filing timelines.

• Rare Disease / Orphan Drug Access Expertise: In-depth knowledge of the unique evidentiary challenges in rare disease drug development, including natural history study design, registry utilization, surrogate-to-clinical endpoint translation, external control arms, and specialized HTA assessment pathways (e.g., NICE Highly Specialised Technologies [HST]).

• Dual Strategic & Execution Capability: Proven ability to define strategic vision at the leadership table while rolling up sleeves to execute and quality-check complex technical models, statistical analysis plans, and dossier sections.

• Collaborative Partnership with Regional Teams: Demonstrated success collaborating with regional HEOR teams (particularly dedicated EU/INT teams) to co-create HTA strategies without duplicating roles.

• Cross-Functional Matrix Leadership: Outstanding ability to influence cross-functional peers and senior leadership across Clinical Development, Medical Affairs, Market Access, and Commercial without formal authority.

• Communication & Scientific Track Record: Exceptional written and verbal communication skills, with an established record of HEOR and clinical publications in peer-reviewed medical and economic journals, or HTA success

Required/Preferred Education and Licenses

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

• Experience:

• Minimum of 7–10 years of experience in HEOR, Global Value, or Health Economics within the biopharmaceutical industry or a top-tier HEOR consulting firm.

• Experience with neurology assets preferred.

• Direct experience 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 on evidence needs as part of Phase2/3 protocol development.

• Launch lead for at least 2 assets as US HEOR lead, or country level HTA lead

• Preferred above country HEOR product leadership

• Proven track record serving as the US HEOR lead or driving US pre-launch HEOR deliverables (e.g., AMCP PIE dossiers, US budget impact models, payer field enablement), or significant exposure to these deliverables from a global role..

• Preferred direct experience in rare disease, orphan drug, or highly specialized pipeline programs, demonstrating innovative approaches to overcoming small sample sizes and evidentiary uncertainty.

• Demonstrated hands-on experience designing, overseeing, or adapting health economic models (cost-effectiveness, budget impact, early conceptual models).

• Demonstrated track record of collaborating with regional HEOR teams (e.g., EU/INT) to deliver evidence packages supporting HTA readiness and submissions.

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