Dharmi Tailor – Roivant Sciences

Dharmi Tailor is multilingual, but not in the traditional sense: she speaks scientist and inventor.

As partner and head of legal for Roivant—a biotechnology and healthcare company—and with a bachelor’s degree in public health policy and management, she understands and can interpret the highly technical speak of researchers and clinicians. That’s allowed her to do everything from getting clinical trials started to ensuring researchers have the tools they need, including proper documentation.

With specific expertise but also serving as a generalist, she’s also helped Roivant start up more than 10 companies over the past five years. That’s meant having a hand in every department.

Dharmi Tailor | Partner and Head of Legal | Roivant Sciences

“I walk a mile in everyone’s shoes, so I can offer tailored legal advice from corporate and healthcare compliance to crafting licensing deals,” Tailor says.

In fact, one of Tailor’s many legal responsibilities includes functioning as a general counsel for Roivant’s spin off companies. As a senior lawyer, she handles all the entities’ legal needs, including strategic and corporate oversight.

“Having a wide range of knowledge was certainly an advantage in answering complex questions from all parts of the business,” Tailor says. “It became fairly imperative during the global pandemic.”

Thinking outside the bottle

Tailor says Roivant often deals with typically strict guidelines, like the number of trials and length of trials needed to test a drug’s safety and efficacy to gain approval from the U.S. Food and Drug Administration. And while guidelines needed to be followed, the pandemic meant that patients couldn’t wait years for a vaccine or drug to prevent or combat COVID-19.

“It was a valuable learning experience for all involved, particularly in expediting drug trial time,” explains Tailor. “That’s one of our main focuses at Roivant.”

For her part, Tailor oversaw regulatory filings and applications for funding as the trials for COVID-19 vaccines progressed. She also helped shorten the lengthy process most academic institutions use to be labelled as a clinical trial site.

“Typically, matters like these can take a handful of months. I was determined to significantly decrease that delay,” says Tailor, who managed to cut the startup time for some sites down to two weeks.

Once the trial sites were up, she continued managing legal matters, such as communications to FDA and proper interaction between site and sponsor. She also credits Roivant’s corporate structure for her speed in answering legal questions.

While Tailor had not done some of the hands-on trial work since her more junior days, she readily stepped into this project because she wanted to help COVID-19 patients—the stakes were high, she adds.

Carefully going (digitally) viral  

Drug trials also mean complying with the FDA’s guidelines. In particular, the administration has strict rules about promoting unapproved products or drug therapies.

Tailor carefully reviews any external statements—from study subject recruitment materials to PowerPoint presentations to investors or academic institutions—that describe the products or therapies. She also works closely with research and development scientists as well as executives to ensure all statements are accurate and compliant with regulations.

“Positive data or not, until we receive approval, we cannot risk our statements crossing FDA boundaries or giving anyone—patients, academics or investors—incorrect or premature expectations,” says Tailor.

In her role, she also negotiates with executives or with their counsel as executives are promoted, moved between Roivant companies, or leave. With Roivant going from privately owned to public, she even developed a new agreement for executives that standardizes legal terms related to severance, non-competition and compensation, including equity compensation.

“I play an integral role in transactions between Roivant and other pharmaceutical companies, including joint collaborations, in-licensing and out-licensing, and mergers and acquisitions,” says Tailor, who recently led a transaction with a major pharmaceutical company. For that transaction, she negotiated with the company and helped oversee the transfer of ongoing global clinical trials, materials, and know-how.

Lawful dancing

Tailor took a somewhat unorthodox career path, switching from pre-med undergrad to pre-law. Attending the University of North Carolina at Chapel Hill, she earned her law degree there as well as her bachelor’s degree in public health, health policy and management.

In her first few jobs, she says she learned how to both navigate drug development processes (standard operating procedures and manufacturing substances) and legal processes (terms and negotiation) in the same context—something that’s been particularly helpful with her work at Roivant, she says.

In fact, her diligence and unique skillset earned her the Triangle Business Journal’s “40-under-40” mention for the Raleigh-Durham area of North Carolina, she says. Tailor particularly enjoys breaking down a law into its components.

“When an internal business client approaches me with a question or idea, I consider all applicable legal areas, such as privacy restrictions on data release and FDA regulations,” Tailor says.

She enjoys the same structure and component quality of poetry, whether she is reading or composing it. She loves dancing, choreography and constructing a perfect meal.

“As a lawyer, I always want to effectively deliver my point. Poetry, dance or picking the perfect food ingredients are but other forms of beautifully structured communication,” Tailor says.

View this feature in the Vanguard Fall IV 2021 Edition here.