Job Description:
Job Summary
The Executive Director, Government Affairs & Policy is responsible for developing and executing a comprehensive government relations and policy strategy to advance the organizations mission of delivering innovative therapies to patients with rare diseases. This leader will serve as a primary liaison with policymakers, trade associations, and other key stakeholders at the federal and state levels, ensuring the organizations perspectives are effectively represented in legislative and regulatory discussions.
Key Responsibilities
-
Strategic Leadership: Develop and implement government affairs strategies aligned with corporate objectives. Advise senior leadership on policy trends, legislative activities, and regulatory developments impacting the biotech and rare disease landscape.
-
Policy Development & Advocacy: Lead efforts to shape healthcare policy, reimbursement frameworks, and regulatory initiatives supporting rare disease innovation and patient access. Prepare position papers, policy briefs, and testimony for engagement with policymakers and agencies.
-
Stakeholder Engagement: Build and maintain relationships with legislators, agencies, trade associations, and coalitions to promote policy alignment and amplify the organizations advocacy voice. Represent the company at industry forums and public hearings.
-
Internal Collaboration: Partner cross-functionally with teams such as Clinical Development, Regulatory Affairs, Market Access, and Corporate Affairs to ensure cohesive alignment between policy goals and business objectives.
Qualifications
-
Bachelors degree in Political Science, Public Policy, Law, Life Sciences, or a related field required; advanced degree (JD, MPP, MPH, or MBA) strongly preferred.
-
At least 12 years of progressive experience in government affairs or policy roles, including 7+ years within the biopharmaceutical or healthcare sector.
-
Proven track record of engagement with federal and state policymakers, ideally within rare disease, orphan drug, or biotech domains.
-
Strong understanding of healthcare policy, reimbursement systems, and regulatory frameworks.
-
Experience collaborating with federal agencies (FDA, CMS, NIH) and state legislatures.
-
Exceptional communication, negotiation, and coalition-building skills.
-
Strategic thinker with the ability to influence high-level stakeholders and navigate complex political environments.
Key Attributes for Success
-
Passion for improving patient outcomes in rare diseases.
-
Strong advocacy and relationship-building abilities.
-
Collaborative leadership style suited to a dynamic, fast-paced environment.
-
High integrity, sound judgment, and emotional intelligence.