For the first time this autumn, the Clinical Trials Management and Regulatory Compliance certificate will offer an online class on project management specifically tailored to the pharmaceutical industry. Co-taught by Dee Suberla and Matt Curin, who together bring over half a century of pharmaceutical industry experience to the classroom, Project Management and Leadership in the Healthcare Industry grounds students in the fundamentals of project management while focusing on the unique challenges posed by projects tasked with bringing new therapies and medical devices to the market.
Complete the form to learn more about the Clinical Trials certificate.
“There are really two aspects to project management in the pharmaceutical industry that make it different from other industries,” says Curin, who is currently executive director of program management at Epizyme. “First, because the ultimate role these products play in our lives is so sensitive, the industry is very heavily regulated. Second—and this stems from the first—the rigorous testing and oversight mean that the approaches to measuring and optimizing efficiency you have in other industries don’t function in the same way when it comes to healthcare project management.”
In other respects, however, Curin notes that project managers in the pharmaceutical industry face a set of challenges and obstacles that are similar to those faced by project managers in other industries. Foremost among these is that project managers are tasked with managing a team of smart and specialized professionals whose variety of functions means they report to their own function leads, not the project manager.
“So you don’t have positional authority as a project manager,” Curin points out. “You have to influence a team of people with different skillsets and priorities who potentially aren’t even so eager to be on the team in the first place. They might even rank two or three levels above you, so it’s possible they’ll question your authority from that standpoint as well. One of the key challenges then is getting people to think about what’s best for the team as opposed to their individual functions.”
“You’ll have scientists, statisticians, engineers, and manufacturers all sitting in the same room and it’s your job to drive the project forward. So in addition to the tools and templates of project management, it’s having the confidence with the soft skills that allows project managers to understand how people fit together so that you can get the best out of them.” —Dee Suberla
For this reason, a central focus of the course will involve concentrating on soft skills like leadership and communication. Whether it is building rapport among team members or creating a safe environment for them to feel free to voice their opinions, high-functioning teams are always good at communicating. In fact, Curin calls communicating and creating open channels for effective communication 90% of what a project manager does.
“It’s particularly challenging for pharmaceutical industry projects where knowing the language of the science side is as important as understanding the business side,” adds Suberla, who worked at Baxter Healthcare for 30 years and has been a consultant, speaker, and coach for the pharmaceutical and medical device industry since 2010. She is also the author of Poof You’re a Project Manager and other Delusions of Grandeur.
“You’ll have scientists, statisticians, engineers, and manufacturers all sitting in the same room and it’s your job to drive the project forward. So in addition to the tools and templates of project management, it’s having the confidence with the soft skills that allows project managers to understand how people fit together so that you can get the best out of them," Dee says.
Given the situational nature of many of the decisions that take place in project management, the class will use scenarios in which students, working in teams, will confront problems that involve drawing on their own work and life experience—in addition to their team-working ability—to find a solution. While knowing the tools and techniques of project management are essential, notes Suberla, you also need the leadership ability that allows you to gain the trust of your team members.
“What happens if someone doesn’t show up to a meeting?” Suberla offers as an example. “How do you hold team members accountable? It’s really about building relationships and removing obstacles so that your team knows you’re there to facilitate the project and let them do the real work.”
“Every team’s dynamics are unique and every decision comes with sub-optimal consequences in other areas,” adds Curin. “That’s why a lot of what Dee and I will teach involves developing critical thinking. In the end, project management is about building relationships and creating emotionally safe environments that allow people to share their ideas without the fear of being judged.”