Sr. Director, US Policy Strategy
hace 2 días
Washington
Reporting to the Head of US Patient Advocacy & Government Affairs, as the Sr. Director, US Policy Strategy, you will lead CSL’s US health policy and market access policy strategy, serving as the company’s principal US policy expert. You will assess legislative and regulatory developments, identify risks and opportunities, develop policy positions, and shape advocacy strategies that support CSL’s business, portfolio, pipeline, and patient access priorities. In this role, you will oversee the full range of federal and state policy issues affecting CSL, including drug pricing reform, government payer and reimbursement policy, 340B, PBM reform, intellectual property, trade, tax, and manufacturing and supply chain policy. You will partner across Government Affairs and Advocacy, Market Access, Legal, Commercial, Medical Affairs, Regulatory Policy, Communications, Finance, Manufacturing/Supply Chain, and US/global Therapeutic Area teams to translate complex policy issues into clear business implications and actionable strategies. You will also represent CSL with policymakers, government agencies, trade associations, industry coalitions, think tanks, and other external stakeholders.You will keep patients and plasma donors central to CSL’s policy work, advancing strategies that support access to innovative therapies, address unmet medical needs, and strengthen CSL’s portfolio across Immunology, Hematology, Cardiovascular and Metabolic, Transplant, and Respiratory. This is a hybrid role, requiring three (3) days of onsite work weekly. Strategic Policy Leadership • Develop and lead CSL’s federal and state health policy strategy, aligned with corporate, commercial, market access, and therapeutic area priorities., • Monitor, analyze, and forecast legislative and regulatory developments across the full US policy landscape affecting CSL, including drug pricing reform, Medicare and Medicaid policy, 340B, rebate and PBM reform, intellectual property and patent policy, trade policy, tax policy, and manufacturing and supply chain policy., • Identify US policy risks and opportunities across CSL’s portfolio and pipeline, and develop strategies to address business, access, reimbursement, and patient impact., • Lead development of CSL’s US policy positions, advocacy priorities, talking points, policy materials, and executive-ready briefings., • Serve as the internal subject-matter expert on policy trends affecting CSL’s therapeutic areas, pipeline, commercial operations, payer strategy, and broader business environment. Market Access, Reimbursement, and Business Strategy • Shape CSL’s broader market access policy strategy, ensuring policy positions support payer, provider, reimbursement, and patient access objectives across commercial and government channels., • Analyze policy developments across Medicare Parts A, B, C, and D, Medicaid coverage and pricing, value-based payment agreements, and other government payer policies relevant to CSL’s portfolio., • Partner with Market Access, Payer Strategy, Commercial, Finance, and other business functions to assess quantitative and qualitative impacts of policy proposals and inform launch, pricing, reimbursement, and access decisions., • Support business development, M&A, and product strategy decisions with policy risk assessments and strategic policy counsel. Government and Stakeholder Engagement • Lead access-focused policy strategy and advocacy with key government policymakers, payers, and influencers, including CMS, HHS, and other relevant federal and state agencies., • Represent CSL before trade associations, industry coalitions, policy think tanks, cross-company working groups, and other external stakeholders to advance CSL priorities., • Manage relationships with outside policy consultants and oversee related policy budgets, as appropriate. External Advocacy and Policy Submissions • Lead development of comment letters, testimony, position papers, policy submissions, and other advocacy materials in response to proposed rules, legislation, guidance, and other policy developments., • Develop evidence-based policy arguments and advocacy materials that clearly communicate CSL’s positions and business priorities to policymakers and external stakeholders., • Track and respond to policy developments affecting market access, reimbursement, intellectual property, trade, tax, manufacturing, supply chain, and patient access. Cross-Functional and Global Collaboration • Partner closely with Government Affairs, Legal, Market Access, Payer Strategy, Commercial, Marketing, Medical Affairs, Communications, FDA Regulatory Policy, Finance, Manufacturing/Supply Chain, and global Therapeutic Area teams to integrate policy strategy with business strategy., • Provide policy expertise and insights to internal business leaders, including clear, succinct briefings for senior executives on policy risks, opportunities, and business implications., • Contribute to global Therapeutic Area policy strategies, particularly for mid- to late-stage pipeline candidates, by identifying US policy risks and opportunities and developing strategies to support long-term portfolio success., • Serve on the US Policy, Advocacy and Government Affairs (PAGA) Leadership Team and help shape the broader US policy, advocacy, and government affairs agenda., • Bachelor’s degree required; advanced degree such as J.D., M.P.H., M.P.P., or similar discipline preferred., • Minimum 15 years of experience in health policy, government affairs, market access policy, or a related field; pharmaceutical, biotechnology, Capitol Hill, CMS/HHS, trade association, or comparable experience preferred., • Demonstrated leadership of a policy function or major policy portfolio, with the ability to set strategic priorities aligned with business needs, translate them into an actionable agenda, and drive execution across multiple workstreams., • Proven ability to lead complex, high-impact projects from strategy through implementation, including defining scope and outcomes, determining internal and external resource requirements, establishing clear roles and timelines, and holding teams accountable for results., • Strong judgment and executive presence, with the ability to anticipate emerging issues, make decisions amid ambiguity, advise senior leaders, and mobilize cross-functional partners without direct authority., • Deep understanding of the US healthcare and pharmaceutical policy environment, including federal and state policymaking, executive branch processes, CMS rulemaking, congressional dynamics, and major healthcare industry associations., • Strong knowledge of pharmaceutical pricing, reimbursement, and access policy, including Medicare, Medicaid, 340B, value-based arrangements, rebate and PBM reform, and government payer policy, with familiarity across intellectual property, trade, tax, manufacturing, and supply chain policy., • Proven ability to assess policy developments and business implications, establish clear recommendations, and develop executive briefings, policy positions, and external policy submissions., • Established relationships with stakeholders influential in healthcare, pharmaceutical, market access, and reimbursement policy, and experience shaping legislative or regulatory outcomes that support patient access, business priorities, and long-term portfolio strategy., • Demonstrated ability to build alignment across functions and levels of the organization, deploy internal expertise and external partners effectively, and manage competing priorities in a fast-moving environment., • Familiarity with policy issues affecting plasma-derived therapies and CSL’s therapeutic areas preferred. Travel Requirements: • Domestic and International travel may be required from time to time.
Antonia C.Activo hace 12 días
