Director, Global Value and Health Economics and Outcomes Research (London)
hace 3 días
London
If you are a current Jazz employee please apply via the Internal Career site. \n Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. \n The Director, Global Value and HEOR is a strategic and execution-oriented leadership role accountable for the global and US payer evidence strategy across marketed assets in Jazz' neurology portfolio. This role is responsible for maximizing brand potential, defending value, securing expanded access, and driving evidence generation across the post-launch lifecycle—including label expansions (sNDA/sBLA), new formulations, line extensions, and competitive market shifts. \n Operating across both broad commercial disease areas and high-uncertainty rare diseases, the Director serves as the strategic evidence engine substantiating the evolving product value story developed by the Market Access team. As a vital stakeholder in the Integrated Evidence Generation Plan (IEGP) governance and brand strategy forums, this role translates commercial, access, and policy priorities into methodologically sound evidence generation plans and tangible deliverables—including updated global core economic models, real-world observational studies, patient registries, Global Value Dossiers (GVDs), and US AMCP dossiers. \n The Director carries a dual global and regional leadership mandate: serving as the dedicated US HEOR lead (partnering directly with US Market Access, Pricing & Contracting, US Medical Affairs, and the Payer Field Team) while collaborating seamlessly with the EU/INT HEOR team to co-create HTA re-assessment strategies and deliver post-launch evidence packages. \n 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. \n Essential Functions/Responsibilities \n 1. Lifecycle Management (LCM), Label Expansions & Indication Sequencing \n\n • Evidence Strategy for Label Expansions: Lead the HEOR evidence generation strategy supporting supplemental regulatory filings (sNDA/sBLA) for new indications, line extensions, expanded patient subpopulations, and novel delivery formulations/devices.\n, • Phase 3b/4 Trial & Pragmatic Study Optimization: Partner closely with Medical Affairs, Clinical Development, and Biostatistics to embed payer-relevant comparative endpoints, patient-reported outcomes (PROs), and health-related quality of life (HRQoL) measures into Phase 3b/4 protocols, pragmatic trials, and expanded access programs.\n, • Indication Sequencing & Access Strategy: Partner with Market Access to evaluate evidence requirements across multi-indication lifecycles, ensuring timely delivery of comparative effectiveness and economic evidence to accelerate access upon label expansion.\n, • Rare Disease Registry & Long-Term Follow-Up: For rare disease inline assets, collaborate on long-term prospective registries, natural history extensions, and post-authorization safety/efficacy studies (PASS/PAES) to address regulatory/HTA commitments, characterize disease progression, and mitigate data uncertainty associated with small cohorts.\n\n 1. Inline Value Defense, HTA Re-Assessments & Evidence Optimization \n\n • Value Defense Against Market Entrants: Proactively identify competitive threats, standard-of-care shifts, and generic/biosimilar erosion; design and execute rapid-response comparative effectiveness, adherence, and burden-of-illness studies to defend product differentiation and access positioning.\n, • Collaborative HTA Re-Assessments & Renewals: In close partnership with the EU/INT HEOR team, co-create evidence strategies and deliver analytical packages (e.g., updated network meta-analyses [NMAs], indirect treatment comparisons [ITCs], and mature economic models) required for HTA re-evaluations, conditional reimbursement reviews, and price renegotiations across major global agencies (such as EU JCA, NICE, G-BA, HAS, CADTH).\n, • Converting Conditional Access to Permanent Reimbursement: In specialized and rare disease indications, design real-world data collection programs to fulfill post-launch evidentiary commitments and convert conditional or temporary reimbursement arrangements into permanent market access.\n, • Global Core Deliverable Updates: Direct the ongoing maintenance and substantive updates of Global Value Dossiers (GVDs), systematic literature reviews (SLRs), and meta-analyses to incorporate mature clinical trial outcomes, newly published real-world evidence, and emerging competitor data.\n\n 1. US Inline HEOR Leadership & Payer Field Enablement (Dual Global/US Mandate) \n\n • Direct US HEOR Accountability: Serve as the designated HEOR expert for assigned inline products in the US market, translating US brand and access priorities into high-impact health economic deliverables.\n, • AMCP Dossiers & Formulary Evidence: Lead the authoring, annual maintenance, and reactive dissemination of compliant, comprehensive AMCP Dossiers, unbranded value summaries, and state Medicaid submission dossiers.\n, • Payer Field Team Strategy & Enablement: Partner closely with the US Payer Field Team and US Medical Affairs to design, develop, and train on customer-facing interactive economic models (budget impact tools, cost-of-care calculators) and reactive scientific presentations.\n, • Regulatory Compliance in Payer Communications: Ensure all US HEOR deliverables, economic models, and field materials adhere strictly to FDAMA Section 114, 21st Century Cures Act, and FDA guidance governing the communication of Health Care Economic Information (HCEI) to population health decision-makers.\n, • Innovative Contracting & Value-Based Agreements (VBAs): Collaborate with US Market Access, Pricing, and Contracting to evaluate the feasibility of outcomes-based risk-sharing agreements; identify measurable, clinically validated real-world endpoints and establish tracking frameworks using claims or EHR data.\n, • US Policy, ICER & Value Framework Preparedness: Monitor evolving US health policy (e.g., Inflation Reduction Act [IRA] Part B/D redesign, CMS price negotiations); develop strategic evidence plans and reactive materials to engage with or respond to evaluations from the Institute for Clinical and Economic Review (ICER) and other value assessment bodies.\n\n 1. Advanced Health Economic Modeling for Inline Products \n\n • Creative Lifecycle Modeling Strategies: Formulate and execute sophisticated health economic modeling strategies tailored for marketed products (including cost-effectiveness, cost-utility, budget impact, and cost-offset models).\n, • Model Adaptation with Mature Clinical & Real-World Data: Transition early trial-based conceptual models into mature, data-rich economic models incorporating long-term survival extrapolations, real-world treatment patterns, dosing adherence, and observational utility weights.\n, • Addressing Structural Uncertainty in Mature Disease States: Deploy innovative modeling approaches (such as partitioned survival, Markov state-transition, microsimulation, and dynamic population transmission models) to tackle complex combination therapy sequencing, treatment switching, and heterogeneous rare disease patient trajectories.\n, • Dynamic Budget Impact Modeling: Build transparent, user-friendly US commercial, Medicare Advantage, and state Medicaid budget impact models that allow customizable formulary tiering, rebate dynamics, and market penetration scenarios.\n\n 1. Cross-Functional Strategic Partnership & Evidence Governance \n\n • IEGP Stakeholder for Marketed Brands: Serve as the core GVHEOR representative on the Integrated Evidence Generation Plan (IEGP) governance for inline assets, ensuring all post-marketing HEOR studies and budgetary milestones are clearly aligned with brand objectives and delivered on schedule.\n, • Strategic Partner to Market Access: Work in lockstep with Market Access to ensure the payer evidence plan directly validates and updates the product value story in response to real-world utilization and payer coverage shifts.\n, • Cross-Functional Matrix Leadership: Partner cross-functionally with Medical Affairs, Commercial Brand Leads, Regulatory Affairs, Biostatistics, and RWE to ensure strategic alignment across all post-launch evidence initiatives.\n, • Evidence Dissemination & Publications: Drive the strategic post-marketing HEOR publication plan; lead the writing and submission of manuscripts to high-impact peer-reviewed journals, and present real-world and\n
