Director, U.S. Federal and State Health Policy and Access, Rare Disease

This role leads the development and execution of an integrated U.S. health policy strategy aligned with AstraZeneca enterprise priorities to support patient access advance launch and lifecycle readiness and enable long-term innovation for Alexions rare disease portfolio. The role is integral to the success of the U.S. Commercial organization.

Youll sit at the intersection of health policy and regulatory policy shaping federal and state environments to enabletimelyandappropriate patientaccess to innovative therapies particularly for complex and next-generation treatments including cell and gene therapies.

What youll do

U.S. Health Policy Strategy & Environment Shaping

• Lead the development and execution of a comprehensive U.S. federal and state health policy strategyaligned to Alexions rare disease portfolio and enterprise priorities.

• Shape the external policy environment to support innovation sustainability and patient accessfor rare disease therapies.

• Identifyand address systemic policy barriersacross diagnosis referral pathways treatment initiation andcarecoordination.

• Anticipate and influence policyneeds foradvanced and next-generation therapies including cell and gene therapies.

• Develop andmaintainpolicy positionsthat support the long-term growth and sustainability of the rare disease ecosystem.

• Lead and coordinate a one team Alexion view on policy impacts and strategies; serve as the primary Alexion representative in broader AstraZeneca working groups to ensure calibration and unified positions.

Policy Integration with Access Regulatory and Lifecycle Strategy

• Serve as primary health policy partner to Market Access ensuring federal and state policy considerations are integrated into brand and lifecycle planning.

• Translate evolving policy and regulatory dynamics into strategic implications for coverage reimbursement and patient access without direct ownership of access strategy execution.

• Partner with Regulatory Affairs to ensure alignment between health policy strategy and regulatory policy priorities translating regulatory developments into broader policy implications.

• Support alignment on integrated policy approaches across FDA CMS and state regulators while respecting functional ownership.

• Provide policy input to support launch readiness and lifecycle planning including identification of risks opportunities and mitigation strategies.

External Engagement Advocacy & Stakeholder Leadership

• Lead engagement with federal andstatepolicymakers regulators and agencies(e.g. CMS HHS state Medicaid programs) to shape policiesimpactingrare disease.

• Partner withFederal and StateGovernment Affairs to drive coordinated advocacy strategies legislative engagement and policy campaigns.

• Lead engagement with trade groups and policy coalitions and partner with Patient Advocacy Global Patient Experience and Medical Affairs teams to support engagementwith externalstakeholders..

• Support policy approaches that enable provider readiness diagnostic pathways and coordinated carefor rare disease patients.

Strategic Insight Evidence & Enterprise Alignment

• Identifykey evidence gaps relevant to policy and access decision-makingand partner cross-functionally to inform evidence generation priorities.

• Leverage data real-world evidence and insights to support policy positioning and external engagement.

• Provide actionable policy insights and recommendationsto U.S. leadership to inform business strategy and decision-making.

• Monitor and assess emerging policy trendsestablishingearly warning systems and scenario planningfor key risks (e.g. IRA Medicaid 340BPBM reforms andutilizationmanagement).

• Ensure alignment across Corporate Affairs Market Access Regulatory Medical and Commercial teams supporting integrated enterprise positions.

Essential for the role

• Bachelors degree

• 8 years of experience in health policy or government affairs

• Pharmaceuticalexperiencein a healthcare policyreimbursementor market access or payer experience (CMS health planPBM) or related healthcare policy consultinglawor financial/actuarial firm.

• Expertisein U.S.federal and statehealth policy affecting rare disease or specialty medicines.

• Knowledge of Medicare Medicaid Marketplace VA DoD 340B and Commercial programs and payer policies reimbursement processes and reimbursement coding inclusive of strategy development

• Experience engaging external stakeholders and alliances.

• Strong strategic analytical and communication skills(oral and written).

Desirable for the role

• Advanced degree(e.g.MBA. JD MHA MPH).

• Strong knowledge of FDA regulatory frameworks and approval pathways (NDA BLA accelerated approval priority review REMS labeling post marketing commitments).

• Experience working in a matrixed organization.

• Experience partnering with Market Access and Regulatory Affairs.

Office Working Requirements

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

The annual base pay for this position ranges from $166324.00 - 249486.00 USD. Our positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs paid time off (i.e. vacation holiday and leaves) as well as health dental and vision coverage in accordance with the terms of the applicable plans.

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