Director, Science Policy and Advocacy

The development of lifesaving vaccines and treatments for infectious diseases is increasingly hindered by the surging cost and difficulty of generating high-quality evidence in humans through clinical trials. 1Day Sooner is working to change that through “Clinical Trial Abundance (CTA),” a national advocacy campaign to reduce the cost of health evidence and extract more value from the evidence we have. As Director, Science Policy and Advocacy, you will lead the CTA program and drive progress toward policy change through legislative vehicles such as the Prescription Drug User Fee Act, as well as regulatory rulemaking and guidance.

Reporting to and working closely with the President, you will set and advance the CTA agenda, managing all aspects of the program, including strategy, policy development, advocacy, partnerships, stakeholder engagement, budget, hiring, and team performance. You will lead a team of four and grow that team as we scale, building the processes and structure to execute the CTA strategy while supporting professional development and growth. CTA is fueled by a recent multi-million-dollar grant and as 1Day secures additional funding, this role will be central to building the broader movement for clinical trial policy reform, convening researchers, patient advocates, industry stakeholders, and funders together to remove unnecessary barriers slowing innovation in public health.

The AI boom presents enormous potential to improve human health and save lives, but the trend toward greater cost of human data must be reversed or it will create a bottleneck, strangling that potential. Our vision over the next ten years is to reshape the FDA of the 21st century as profoundly as the post-thalidomide era changed the FDA of the 20th. We aim to increase the value of health evidence being generated by 10x at 1/10 the current average cost.

How You’ll Make An Impact

You will build on 1Day Sooner’s record of advancing ambitious campaigns in science, policy, and ethics to stop the world’s most harmful infectious diseases. With a strong understanding of federal advocacy and lobbying, you will develop and advance legislative, regulatory, and appropriations strategies. You are comfortable taking and defending bold positions while effectively navigating complex policy and stakeholder environments. See here for an account of our impact through mid-2024. Early performance expectations for this role include:

• Introducing bipartisan, bicameral legislation that includes some of our priorities.
• Building out the program’s core processes—policy development, advocacy tracking, information management, and stakeholder management—so that the team can operate quickly and efficiently as it scales.
• Deepening 1Day’s relationships across the clinical trial policy ecosystem, positioning 1Day as the field’s most useful partner.
• Developing an agenda for policy changes that can be achieved through regulatory change under existing statutory authority.

Work Environment, Salary, and Benefits

• Although 1Day operates as a fully remote organization with no physical office, the nature of this role requires regular presence in Washington, DC. Candidates must be based in the DC area.
• Depending on background and experience, we expect the salary for this position to fall within a range of $150K – $220K. The salary offered will be commensurate with experience. 1Day offers an outstanding benefits package, including 15 vacation days plus federal holidays and an office closure between Christmas and New Year’s; 15 fully paid sick days; 5 paid days of professional development leave; parental and bereavement leave; generous health and wellness benefits through an Individual Coverage Health Reimbursement Arrangement (ICHRA) for you and your family; a 401(k) match of up to 6%; and a professional development stipend.

Responsibilities

• Set and execute program strategy. Develop the CTA program’s policy agenda and field-building strategy with the President, and translate it into concrete campaigns, milestones, and timelines. Here is a description of our current strategy. 
• Supervise policy development. Oversee the development of legislative text, appropriations language, executive orders, and regulatory text that operationalize the program’s policy goals. 
• Oversee advocacy and lobbying. Direct the program’s federal advocacy strategy and oversee the work of the Advocacy Director and external lobbyists, including stakeholder and legislative recruitment, grassroots outreach, events, and press.
• Manage the team. Manage the CTA team, including hiring, performance reviews, and professional development, in collaboration with People Operations.
• Manage the program budget. Manage the program’s overall budget within approved annual constraints and make decisions on program-specific spending.
• Support fundraising. Partner with 1Day’s leadership on grant strategy and funder relationships for the program.
• Represent 1Day publicly. Serve as a senior public face of 1Day’s clinical trial reform work in meetings with policymakers, at conferences and convenings, with press, and in published commentary.

Qualifications

• 10–20 years of experience in policy, advocacy, or government affairs, ideally with exposure to FDA regulation, drug development, clinical research, or related federal health policy areas. We welcome candidates from adjacent fields who bring high-level advocacy experience, scientific fluency, and the demonstrated ability to quickly master complex subject matter.
• Strong understanding of federal advocacy and lobbying with demonstrated ability to develop and advance legislative, regulatory, and appropriations strategies, and comfort taking and defending bold, ambitious positions.
• Experience managing, mentoring, and developing a team, with the ability to build capacity as a program grows.
• Proven ability to build relationships with government agencies, legislators, administration officials, and mission-aligned partners. 
• Ability to prioritize across multiple workstreams, manage competing timelines, make important decisions with appropriate consultation and communication, and keep complex projects moving.
• A commitment to 1Day’s mission, vision, and values.

About 1Day Sooner

1Day Sooner represents altruistic medical research participants. We have run successful advocacy campaigns in the U.S. (at both the federal and state levels), U.K., and Africa which have collectively impacted billions of dollars in spending and been covered globally in outlets such as the New York Times, CNN, the BBC, and Nature Magazine. We have published in journals such as the American Journal of Bioethics, the Journal of Infectious Diseases, the Lancet Journal of Gastroenterology and Hepatology, and Nature Reviews Immunology.

Internally, this position title is: Program Director, Clinical Trial Abundance

Further resources/reference documents:

• CTA white paper
• CTA PDUFA grant proposal
• CTA February grant proposal