Executive Director, Head of Government Affairs

About the role

At Insmed, the Head of Government Affairs will serve as the primary liaison to federal and state legislative and regulatory bodies, building and maintaining relationships that support the company's mission and commercial objectives. This role will manage Insmed’s relationship with industry organizations and develop and execute a comprehensive government affairs strategy, working cross-functionally with various teams.

Responsibilities

• Develop and lead a comprehensive government affairs strategy at the federal and state levels, aligned with the company's pipeline, commercial, and corporate priorities.
• Monitor legislative and regulatory developments (including FDA policy, drug pricing, market access, and rare disease policy) that may impact Insmed's business and proactively communicate implications to senior leadership.
• Build and maintain productive relationships with Members of Congress, congressional staff, federal agency officials (FDA, HHS, CMS, NIH), and relevant trade associations.
• Represent Insmed's positions on key policy issues including rare disease drug approval pathways, reimbursement and coverage policies, drug pricing legislation, and public health initiatives.
• Partner closely with Regulatory Affairs, Market Access, Legal, Compliance, Communications, Medical Affairs, and the Executive Committee to align government affairs activities with business needs and ensure a coordinated approach to policy engagement.
• Manage relationships with external government affairs firms and biotech industry organizations.
• Collaborate with Patient Advocacy to advocate for patient advocacy groups and rare disease organizations and amplify Insmed's policy positions and support patient-centered legislative initiatives.
• Lead government affairs preparedness efforts for high-impact, low-probability scenarios (e.g., FDA operational disruptions, regulatory pathway changes), coordinating with outside counsel and cross-functional partners.
• Represent Insmed in relevant industry trade associations (e.g., BIO, NORD, MBAA) and working groups to advance shared policy objectives.
• Provide regular updates to the Executive Committee and Board of Directors on the political and regulatory landscape, emerging risks, and government affairs activities.
• Develop and manage the Government Affairs budget, including external firm retainers and advocacy-related expenditures.

Requirements

• Demonstrated track record of successfully influencing federal healthcare legislation and regulatory policy.
• Deep knowledge of the U.S. legislative and regulatory process, including FDA drug approval pathways, CMS reimbursement policy, and rare disease policy frameworks.
• Established relationships on Capitol Hill and with key federal agencies (FDA, HHS, CMS, NIH).
• Experience managing external government affairs firms, lobbyists, and coalitions.
• Strong strategic thinking, analytical, and problem-solving skills with the ability to translate complex policy issues into actionable business strategies.
• Excellent oral and written communication skills, including the ability to represent Insmed effectively before government officials, industry groups, and patient advocacy organizations.
• Proven ability to work cross-functionally and influence without direct authority in a matrixed organization.
• High degree of integrity, sound judgment, and commitment to ethical conduct.

Qualifications

• Bachelor's degree required; advanced degree (JD, MPP, MBA, or relevant graduate degree) strongly preferred.
• Minimum of 12–15 years of progressive experience in government affairs, public policy, or regulatory affairs, with significant experience in the pharmaceutical, biotechnology, or life sciences industry.

Skills

• Strategic thinking and problem-solving skills.
• Effective communication skills, both oral and written.
• Ability to build and maintain productive relationships with stakeholders.
• Experience in rare disease, orphan drug, or specialty pharmaceutical policy.
• Experience working within a government agency (FDA, HHS, Congressional office) or a leading government affairs firm representing life sciences clients.
• Experience engaging with patient advocacy organizations in the rare disease space.

Benefits

Insmed offers a range of benefits including:

• Comprehensive medical, dental, and vision coverage and mental health support.
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration.
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance.
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back.

Pay

$280,000.00-382,500.00 Annual