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

AstraZeneca•Boston, MA

3d•Hybrid

About The Position

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 Alexion’s rare disease portfolio. The role is integral to the success of the U.S. Commercial organization. You'll sit at the intersection of health policy and regulatory policy, shaping federal and state environments to enable timely and appropriate patient access to innovative therapies, particularly for complex and next-generation treatments, including cell and gene therapies.

Requirements

Bachelor’s degree
8+ years of experience in health policy or government affairs
Pharmaceutical experience in a healthcare policy, reimbursement or market access or, payer experience (CMS, health plan, PBM), or related healthcare policy consulting, law or financial/actuarial firm.
Expertise in U.S. federal and state health 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).

Nice To Haves

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.

Responsibilities

Lead the development and execution of a comprehensive U.S. federal and state health policy strategy aligned to Alexion’s rare disease portfolio and enterprise priorities.
Shape the external policy environment to support innovation, sustainability, and patient access for rare disease therapies.
Identify and address systemic policy barriers across diagnosis, referral pathways, treatment initiation, and care coordination.
Anticipate and influence policy needs for advanced and next-generation therapies, including cell and gene therapies.
Develop and maintain policy positions that 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.
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.
Lead engagement with federal and state policymakers, regulators, and agencies (e.g., CMS, HHS, state Medicaid programs) to shape policies impacting rare disease.
Partner with Federal and State Government 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 engagement with external stakeholders..
Support policy approaches that enable provider readiness, diagnostic pathways, and coordinated care for rare disease patients.
Identify key evidence gaps relevant to policy and access decision-making and 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 recommendations to U.S. leadership to inform business strategy and decision-making.
Monitor and assess emerging policy trends, establishing early warning systems and scenario planning for key risks (e.g., IRA, Medicaid, 340B, PBM reforms, and utilization management).
Ensure alignment across Corporate Affairs, Market Access, Regulatory, Medical, and Commercial teams, supporting integrated enterprise positions.