Manager, Government Affairs

About Soleno Therapeutics Inc Soleno is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases based in Redwood City, CA. At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are – it is in our chromosomes – and our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes, both professionally and for those living with PWS. We value collaboration, integrity, and respect. These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs) and community members we serve. We are proud to work alongside them every step of the way. Our employees are our greatest asset, and we're expanding across functions during this pivotal time. We invite you to join us in making an impact—and making history.We all share the most important goal of bringing solutions to the PWS community. Summary of Job (brief description) The Manager, Government Affairs (GA) will support the implementation of Soleno’s government affairs function. This Manager will engage with government stakeholders at the federal and state levels to help shape a favorable policy environment for rare disease therapeutics (especially PWS), and support access, reimbursement, regulatory alignment, and advocacy initiatives.

Responsibilities

Strategy and Policy

• Monitor and analyze federal and state legislative, regulatory, and policy trends relevant to rare diseases, genetic disorders, and hyperphagia/PWS.
• Support GA function on policy risks / opportunities, developing strategic positions, messaging, and policy asks
• Advocacy and Stakeholder Engagement .
• Build and maintain relationships with policymakers, congressional staff, and executive agencies (e.g., FDA, CMS, NIH, HHS, state health agencies), and trade associations.
• Represent Soleno in coalitions, roundtables, advisory groups, and industry associations (e.g., rare disease advocacy groups, pharmaceutical industry associations)
• • Support GA function in its relationships with patient advocacy organizations, caregivers, and expert communities to align advocacy priorities and share insights

Government and Payer Access Support

• Support GA function with reimbursement, market access, and policy teams to achieve coverage / reimbursement policy goals (Medicaid, Medicare, and other state programs)
• Advocate for patient access, insurance coverage, reimbursement pathways, value, frameworks, and innovative payment models, per the GA strategic plan .
• Support state-level access initiatives (e.g., Medicaid supplemental rebates, state rare disease programs) in alignment with the GA strategic plan

Regulatory and Compliance Interface

• Support GA Director on legislation and rulemaking tracking/education that affects clinical trial regulation, patient access pathways (e.g. expanded access, orphan drug incentives, real-world evidence legislation)

Communications and Messaging

• Draft policy briefs, position papers, stakeholder materials, testimony, talking points, and external communications in support of advocacy and GA function
• Operational and Project Management
• • Support admin functions related to external consultants, lobbyists, or contractors as needed
• Organize visits to Congress / state capitols, briefings, roundtables, and government affairs advocacy events
• Monitoring and Reporting
• • Track key performance indicators (KPIs) for GA programs (attendance, outreach metrics, advocate satisfaction)
• • Generate regular internal reports summarizing activities, insights, and impact
• • Maintain compliance records in line with company policies and industry standards
• • Utilize GA software, like Quorum, to identify and track priority legislation and flag upcoming key advocacy opportunities
• Other
• Other administrative support of Government Affairs function as needed.

Qualifications

• Bachelor’s degree in public policy, political science, health policy, life sciences, or related field (advanced degree preferred)
• • 3-7years of experience in government affairs, public affairs, policy roles, ideally in the pharmaceutical/biotech/life sciences and/or rare disease space
• • Deep understanding of federal and state health policy, regulatory and reimbursement processes (FDA, CMS, Medicaid, state health agencies)
• Proven track record in influencing legislation/regulation, working with policy makers, drafting testimony or regulatory comments, coalition building
• Network of relationships with federal and/or state policymakers, agencies, industry associations, patient advocacy organizations
• • Ability to synthesize scientific/clinical/technical content into policy arguments
• • Strong strategic thinking, analytical, writing, communication, and stakeholder management skills
• High integrity, compliance orientation, familiarity with lobbying laws, ethics, disclosure obligations

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