Healthcare Policy Lobbyist - Biotech Sector

About The Initiative

The Clinical Trial Abundance Initiative addresses the excessive duration, high costs, and outdated regulatory framework of clinical trials in the United States. Its mission is to overhaul federal policies and laws to enable clinical trials to be conducted more rapidly, cost-effectively, and with less complexity, thereby increasing the number of therapies developed.

Supported by leading scientific philanthropies, this founder-led initiative targets the 2027 reauthorization of the Prescription Drug User Fee Act (PDUFA) as a pivotal opportunity for impactful reform. The team leverages successful global models, including notification-based trial pathways in Australia and reforms in the UK.

Role Overview

This role focuses exclusively on policy and legal reform, distinct from operational roles or efforts aimed at trial access, diversity, or equity. The goal is to improve the clinical trial framework to expedite and reduce the expense of launching and conducting trials.

As a founding leader working closely with the Chief Science Officer, you will concurrently manage two strategic timelines: short-term, by influencing legislation and regulation during the PDUFA 2027 process; and medium-term, by cultivating a sustainable coalition representing companies, investors, researchers, patient groups, and policymakers invested in this cause.

Responsibilities

• Act as the initiative’s principal policy representative to lawmakers, federal agency officials, health system leaders, and biotech executives, establishing trust and credibility.
• Develop and advocate a comprehensive reform agenda targeting clinical trial cost, speed, and complexity within the PDUFA 2027 reauthorization and its aftermath.
• Establish and expand a coalition of relevant stakeholders to ensure the longevity and impact of the initiative beyond legislative milestones.
• Collaborate with the Chief Science Officer to translate scientific and regulatory reform arguments for different audiences.
• Chart a strategic course for the initiative extending beyond 2027 focusing on coalition and field development.

Candidate Profile and Qualifications

• Proven expertise and credibility in biotechnology, life sciences, or FDA clinical trial policy, emphasizing subject-matter knowledge over general government affairs.
• Demonstrated ability to engage and be respected by diverse senior stakeholders including Capitol Hill staff, regulatory agencies, industry leaders, investors, and researchers.
• Experience building durable coalitions, institutions, or initiating impactful long-term projects (0→1 experience).
• In-depth understanding of reform rationales aimed at reducing delays, costs, and complexities between scientific breakthroughs and patient access.
• Preferred but not required: experience with PDUFA, user-fee reauthorization processes, or FDA regulatory pathway reform.
• Familiarity with international regulatory frameworks such as those in Australia, the UK, and the EU.
• Established professional network spanning biotechnology, investment, research, and policymaking arenas.

Compensation and Benefits

• Competitive base salary ranging from 200,000 to 250,000 USD annually.
• Comprehensive private health insurance coverage.
• Paid time off for personal and vacation needs.
• Remote work flexibility with options to work from home.
• Opportunities for professional training and development.