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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.

Learn more about Exact Sciences Laboratories.

We conducted an investigational use study or a “test-run” of Cologuard. This provided vital information that helped us identify issues in the system, and make corrections or improvements. This ensured a positive and smooth experience for Cologuard users, both health care professionals and patients, once it was commercially available.

When I first joined the company, our primary focus was on the approval and launch of Cologuard. As the company has grown, so has our workload and we are currently working on multiple projects.

The most critical project we are working on is a post-approval study of Cologuard, as required by the FDA during the review and approval process. This longitudinal study will look at Cologuard testing at a three year interval, providing data that will help establish an appropriate screening interval for Cologuard.

We are also initiating studies that will assist with the adoption of Cologuard internationally, and most recently we have started working on the collection of biological samples for the work being done with MD Anderson on our lung cancer collaboration. 

What positions are open in Clinical Operations? What do you look for when hiring?

We are currently recruiting for a Clinical Research Associate (CRA) position – our eyes and ears out in the field. A CRA’s primary responsibility is to visit study sites and ensure all protocols are being followed properly, that data is being documented appropriately, and assuring that any issues related to the conduct of our trials is being reported back to our Clinical Study Managers.

I look for CRAs to be detail-oriented, responsible and outgoing. Candidates typically have a life sciences background, clinical or research experience, and at least a bachelor’s degree.

How would you describe the culture at Exact Sciences?

Exact Sciences has a great team environment. It starts with the executive team setting clear company goals and communicating the progress we are making toward those goals on a regular basis. Their open approach and enthusiasm for what we do serves as an example to all employees.

Everyone is engaged and comfortable offering ideas and making suggestions, knowing they will be taken in a positive light. On the Clinical Operations Team, we hold weekly meetings to talk about how individual projects are going. These are open discussions, and everyone feels empowered to pitch in with ideas or offer to help with projects.

How do you like living in Madison?

I’m originally from Ohio, so I appreciate the Midwest feel. Madison is teeming with activities, especially on weekends. If you can’t find something to do in and around Madison, you’re just not looking. From the lakes, the university, the great parks, the farmer’s markets, to festivals, concerts, and fairs, there is always something to do.

Madison boasts a vibrant downtown, which is convenient to get to from any of the surrounding areas. There are some great microbreweries and restaurants, and the people are just laid back and fun. If I wake up on a Saturday morning and turn on the local news, I can always find an activity to participate in that day. It’s just a great place to live and raise a family.

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Topics: Exact Sciences News

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