Driven By the Mission: How Toby Vaughn Joined and Helped Build Our Clinical Operations Department

Exact Sciences is recruiting heavily in an effort to support the launch of Cologuard and development of our product pipeline. To support this effort, we'll be publishing Q&As with Exact Sciences team members in the areas we are hiring.

This Q&A features Exact Sciences Sr. Director of Clinical Operations Toby Vaughn.

After spending most of his career working in Clinical Operations in the pharmaceutical industry, working for a medical device company wasn’t on Toby Vaughn’s radar. But after hearing about Exact Sciences and the company’s mission to eradicate colon cancer, he knew this was where he belonged:

Can you please provide an overview of your role and department?

Exact Sciences’ Clinical Operations Department is responsible for managing all clinical trials, working closely with Regulatory Affairs, Medical Affairs, R&D and others on the design, planning, and execution of the trials.

We draft study protocols, prepare consent forms, ensure the studies receive regulatory approval, and monitor the study sites to ensure appropriate execution of the study, and collection of the data.

Any time a study needs to be done involving patients, our team is deeply entrenched. As we have a lot of studies ongoing and in the pipeline, our department has grown significantly in the past year.

Why Exact Sciences?

I had more than 25 years of experience in pharmaceuticals when I was approached for this position at Exact Sciences.

At first, I thought, “Why switch to a medical device company when I have so much experience in pharmaceuticals?” I never imagined leaving the pharma world, but Exact Sciences’ goal to eradicate colon cancer was inspiring. My mother is a colon cancer survivor, so this mission really resonated with me personally.

The Be Seen, Get Screened online educational campaign, which started long before Cologuard was approved, clinched it for me. It spoke to the sincerity and character of the people here at Exact Sciences.They are committed to the cause – it’s personal. It’s not just about selling products. I had to be a part of the company and join them on their mission to wipe out colon cancer.

What role did you play in the Cologuard clinical trial and what are some of your current projects?

I joined Exact Sciences in February 2014, when the primary clinical trials for Cologuard were already completed. Yet the Clinical Operations team was able to contribute right away by assisting with some additional studies aimed at assuring that we were prepared for the commercial launch of Cologuard.

For example, we needed to make sure the test ordering, shipping, processing, and reporting systems were ready. We had this great new lab, but had never tested the ordering and sample processing system in a “real world” situation.