Biotech Operations Manager Jobs in Spring Valley, NY

Clinical trials in the United States take too long, cost too much, and are too tangled in outdated rules — and the country develops far fewer of the therapies it could. The Clinical Trial Abundance Initiative exists to change that at the root: by reforming the federal policy and law that govern how trials are run, so that high-quality trials become dramatically faster, cheaper, and simpler to conduct.

We are a new, founder-led effort backed by a coalition of leading science philanthropies. The 2027 reauthorization of the Prescription Drug User Fee Act (PDUFA) is a rare, high-leverage window to move real reform — and we are building both the organization and the coalition to make the most of it, and to sustain momentum well beyond it. We draw on what already works abroad, from Australia's notification-based trial pathway to reforms across the UK and elsewhere.

This is a policy and law reform role, not an operations or access role. The work is to change the rules — the federal policy and law governing clinical trials — so that more trials can be launched, run, and approved, faster and at lower cost.

To be direct about scope: you will not be operating or running trials, and the role is not focused on trial access, diversity, inclusion, or equity. Those aims matter, but they are a different kind of work. This role exists to make trials themselves faster, cheaper, and more abundant to conduct — by reforming the system that governs them.

This is a founding leadership role, working in close partnership with the initiative's Chief Science Officer to build the effort from the ground up. It runs on two horizons at once.

In the near term, you are the initiative's credible face in policy — the person who can sit across from a Senate HELP or House Energy & Commerce staffer, an FDA official, a hospital system's leadership, or a biotech CEO, and be taken seriously by all of them. You help shape the legislative and regulatory reform agenda and drive it into the PDUFA 2027 window and its implementation.

Over the medium term, you build the field. There is no standing constituency for clinical trial abundance today; your job is to create one — a durable, formidable coalition of companies, investors, researchers, patient organizations, and policymakers who will carry this work long after any single legislative moment.

• Serve as the initiative's lead voice with legislators, congressional staff, and agency officials, and with health-system and industry leaders — building credibility and trust across a wide and varied set of stakeholders
• Shape a substantive agenda to reform the policy and law around the cost, speed, and complexity of trials, and drive it into the PDUFA 2027 reauthorization and its implementation
• Design and build the coalition — recruiting and aligning companies, investors, research and patient organizations, and allied policymakers into a lasting interest group
• Translate the scientific and regulatory case for reform into arguments that move different audiences, in partnership with the Chief Science Officer
• Set the initiative's strategy for the years beyond 2027, when the work is field-building rather than chasing a single deadline

Requirements

• Deep credibility in biotech, life sciences, or FDA / clinical-trial policy — this is a subject-matter role, not a generalist government-affairs one
• A track record of being taken seriously by senior, varied stakeholders: Hill offices, agencies, industry executives, investors, and researchers alike
• Evidence that you can build something durable, not only win a near-term legislative fight — coalition-building, institution-building, or genuine 0→1 experience
• Fluent in the case for reform that expands what's possible — cutting the friction, cost, and time between good science and the patients who need it

• Direct experience with PDUFA, user-fee reauthorizations, or FDA review-pathway reform
• Familiarity with international regulatory models (Australia, UK, EU)
• An existing network spanning biotech, investors, research, and DC policy

Benefits

• Competitive salary of 200000-250000 USD/year
• Private Health Insurance
• Paid Time Off
• Work From Home
• Training & Development