Healthcare Policy Lobbyist (Biotech)

About The Initiative

The Clinical Trial Abundance Initiative aims to overhaul the clinical trial landscape in the United States, where trials currently suffer from excessive duration, high costs, and outdated regulations. The initiative seeks to reform federal policies and laws to enable faster, less expensive, and simpler high-quality clinical trials. Supported by leading scientific philanthropic organizations, the initiative focuses on the critical 2027 reauthorization of the Prescription Drug User Fee Act (PDUFA) as a strategic opportunity to enact meaningful reform, drawing lessons from successful models abroad including Australia and the UK.

Role Summary

This leadership position is dedicated to policy and legislative reform targeting the acceleration, simplification, and cost reduction of clinical trial processes. Unlike operational roles, this position does not involve conducting trials or addressing trial access, diversity, or equity. Instead, the focus lies solely on transforming the federal regulatory framework governing clinical trials.

Key Responsibilities

• Represent the initiative as the primary policy expert interfacing with legislators, congressional staff, FDA officials, hospital executives, and biotech leaders.
• Develop and advance the legislative and regulatory reform agenda for clinical trials, ensuring integration with the PDUFA 2027 reauthorization and its subsequent implementation.
• Establish and expand a sustainable coalition including companies, investors, researchers, patient advocacy groups, and policymakers to promote and maintain momentum for clinical trial reform beyond the immediate legislative period.
• Collaborate with the Chief Science Officer to effectively communicate the scientific and regulatory imperatives for reform to diverse stakeholders.
• Strategize long-term plans for the initiative, preparing for continued field development post-2027.

Candidate Profile

• Extensive expertise and credibility in biotechnology, life sciences, or FDA/clinical trial policy with specialized subject-matter knowledge.
• Proven success engaging senior stakeholders across government, industry, investment, and research sectors.
• Demonstrated ability in building enduring organizations or coalitions beyond short-term legislative achievements.
• Strong understanding of the necessity and benefits of reform that enable the efficient translation of scientific advances to patient care.

Preferred Qualifications

• Experience with PDUFA, FDA user-fee reauthorization processes, or reforms of FDA review pathways.
• Knowledge of international regulatory frameworks such as those in Australia, the United Kingdom, and the European Union.
• Established professional network including biotech companies, investors, researchers, and policy actors in Washington, DC.

Compensation and Benefits

• Competitive annual salary between 200000 and 250000 USD.
• Private health insurance coverage.
• Paid time off for work-life balance.
• Support for working remotely when needed.
• Opportunities for professional training and career development.