CARLY MCWILLIAMS ’05: Science, Public Service, and the Power of Policy

A Foundation Built on Relationships

Carly McWilliams ’05 remembers choosing Hamilton College because it felt familiar. “It reminded me a lot of Millbrook, so I knew I would be comfortable there,” she says. That sense of fit launched her on a path defined by exploration and purpose and rooted in relationships. Her academic interests ranged from communications to art history to education, and a study-abroad semester in Ireland her first year broadened her perspective in unexpected ways. “I had a really great group of 30 kids with me—it was a unique way to start college.”

A series of internships during college shaped Carly’s understanding of what she didn’t want to pursue—fashion, for example. Fellow Millbrook alum and faculty child Holly (Meigs) Noone ’94 got Carly in the door for a fast-paced internship at Tory Burch while the company was exploding with growth. She thought the experience was interesting and cool but easily ruled out fashion and opened her to new experiences. That clarity was a gift: “The process of elimination is a lot easier than figuring out exactly what you do want to do.”

It was during an internship at the 2008 Republican National Convention in Minnesota with Arthur Anthony ’07—thanks to another Millbrook connection, Gordon Pennoyer ’99—that Carly found her calling in operations and a taste for U.S. politics. “I loved it. It got me into politics in the sense that I met people working in government. It was completely serendipitous that I ended up working for the convention’s head of operations based on the fact that I was the only intern old enough to drive him around.”

A Capitol Hill Career: From Clerk to Senior Counselor

After graduating from Hamilton, Carly followed her instincts to Washington, D.C., where she secured an unpaid internship and worked retail on the side for another Millbrook alum, Bill Menard ’78. But she knew she wanted to be working in government, and by 2011, she was working on Capitol Hill as a legislative clerk for the House Energy and Commerce Committee. “It’s one of the oldest committees on the Hill, with the broadest jurisdiction,” she explains. To understand the scope of the committee’s work, “One of the chairmen used to say, ‘If it moves, it’s energy. If it doesn’t, it’s commerce.’”

Over six years, Carly worked her way up to become a professional staff member focused on FDA policy and emergency preparedness. It was the start of a deep dive into medical product regulation, one that led her to work on major legislation like the 21st Century Cures Act—a sweeping, bipartisan effort to modernize healthcare innovation and access, which was enacted into law in December 2016. “It was about making innovation faster and better and ensuring the patient perspective was present in regulatory decision making,” she says. “Looking at the full cycle, from development to delivery, and asking: How are these products helping patients? What can we learn from them?”

Eager to bring a business lens to her policy work, Carly pursued a policy-focused MBA program at the University of Minnesota. “A lot of what drives legislation comes down to economic impact—how does this create jobs, how does it affect our economy, how does this impact Americans and their daily life?” she notes. Her program emphasized the intersection of regulation and industry across sectors like healthcare, technology, and the environment, further preparing her for a transition to the U.S. Food and Drug Administration (FDA).

Shaping National Health Policy at the FDA

Carly joined the FDA in 2017 as a senior counselor to the commissioner, Dr. Scott Gottlieb, and other agency leaders, and she became a key liaison between policy and public understanding. “My job was working on policy priorities but also packaging and communicating the policy clearly—to all stakeholders,” she says. That meant everything from strategic plans and press releases to blog posts and social media initiatives. She even helped launch “tweetorials” with the FDA commissioner to break down complex health issues in digestible weekend threads.

Her time at the FDA also coincided with the COVID-19 pandemic, during which she witnessed an unprecedented regulatory response. “The FDA moved faster than I’d ever seen or imagined could be possible. It was an intense but incredible learning experience that made me admire the Agency and the value they bring to everyone in the country.” Carly worked on a range of issues—from youth tobacco use to diagnostics reform—and developed lasting admiration for the agency’s mission and impact.

Global Reach, Local Impact: Leading Diagnostic Policy at Roche

But government work requires commitment to a very particular calendar of schedules, and work at the FDA was, for the most part, incredibly stressful. This led Carly to decide in 2020 to transition to the private sector and join Roche Diagnostics. Now four years into her role as head of regulatory policy for North America, she provides leadership in shaping the regulatory environment for the largest diagnostic company in the world. “We do everything from COVID tests to oncology diagnostics to strep and flu A/B tests that you take in your doctor’s office,” she says. “The impact of diagnostics on patients cannot be overstated, and I love working for something that I know makes a huge difference for each patient and public health.”

At the intersection of global policy and innovation, Carly works with an international team, collaborating across six continents to advance harmonization of medical regulations across the world with the intent to speed up patient access to vital diagnostic tools. “We’re trying to make regulatory requirements and standards more consistent worldwide,” she explains. “It’s like the Common App for colleges, but for diagnostics.”

Whether she’s shaping policy in D.C. or coordinating regulatory strategy across Europe, Asia, and beyond, she is focused on equity and innovation, especially in how diagnostics serve diverse populations and support public health worldwide.

Carly’s work remains grounded in the values she absorbed at Millbrook: curiosity, stewardship, and a deep sense of purpose. “Every day, I’m learning something new. And I still feel the influence of Millbrook—in how I think, how I communicate, and, most of all, how I connect with people.”