Healthcare Policy Lobbyist - Biotech Clinical Trial Reform

About The Initiative

The Clinical Trial Abundance Initiative is committed to transforming clinical trials in the United States, which currently face delays, high costs, and outdated regulations, resulting in underdeveloped therapies. The initiative focuses on reforming federal policies and laws governing clinical trials to make them faster, more affordable, and easier to conduct. This effort is backed by major science philanthropies and builds upon successful international models from countries like Australia and the UK. The 2027 Prescription Drug User Fee Act (PDUFA) reauthorization presents a crucial opportunity to implement these reforms and sustain progress beyond that date.

Role Overview

This founding leadership position centers on policy and legislative reform rather than operational aspects or issues like trial access, diversity, or equity. The goal is to overhaul the regulatory environment to significantly accelerate and reduce the cost of conducting clinical trials. Collaborating closely with the Chief Science Officer, you will lead policy engagement and coalition building.

Responsibilities

• Act as the initiative's principal policy representative to legislators, congressional staff, FDA officials, healthcare system leaders, and biotech executives, fostering credibility and trust.
• Develop and advocate a legislative and regulatory reform agenda aimed at reducing the complexity, expense, and duration of clinical trials within the PDUFA 2027 reauthorization and its rollout.
• Establish and grow a durable coalition of companies, investors, researchers, patient groups, and policymakers to advance clinical trial abundance long-term.
• Work alongside the Chief Science Officer to translate scientific and regulatory concepts into compelling arguments tailored to diverse stakeholders.
• Chart the initiative's strategic path beyond 2027, focusing on institution-building rather than single-event advocacy.

Candidate Profile

• Extensive expertise and recognition in biotech, life sciences, or FDA/clinical trial policy areas.
• Demonstrated ability to engage effectively with senior stakeholders across government, industry, investment, and research sectors.
• Proven success in building enduring organizations or coalitions rather than short-term legislative achievements.
• Strong understanding of reforms needed to reduce barriers between scientific discovery and patient access to therapies.

Preferred Qualifications

• Experience with PDUFA, user-fee reauthorizations, or FDA review-pathway reforms.
• Knowledge of international regulatory systems such as those in Australia, United Kingdom, and the European Union.
• Existing network connecting biotech, investors, research community, and Washington DC policy makers.

Compensation and Benefits

• Annual salary in the range of $200,000 to $250,000.
• Private health insurance coverage.
• Paid time off.
• Flexible work from home options.
• Opportunities for professional training and development.