Patient-Centricity at the Heart of Clinical Trials


Clinical Operations teams play a critical role in the development of new treatments. Responsible for operational management of clinical trials, they are at the center of the lengthy process of taking a drug candidate through all phases to become an approved treatment available to patients.

From a Small Biotech to a Global Biopharmaceutical Leader

In my role within Global Clinical Operations, I am responsible for leading the strategy and conduct of our clinical trials within Takeda’s Gastroenterology Therapeutic Area Unit.  In Clinical Operations, we seek to find ways to optimize our trials in order to make the process as smooth as possible for patients, physicians, and research colleagues, so that ultimately, we can deliver our treatments faster.

Having been here for almost 15 years, I’ve seen many changes. When I first joined we were a very small biotech, and in those early years we were doing a lot of tasks that today we outsource to global contract research organizations, external partner companies whose support allows us to work smarter and more efficiently.

It’s wonderful to see the results of our work positively impacting patients’ lives.  My career began in the field of rare diseases, and I had unique opportunities to see the first two programs I worked on in succession both file and receive regulatory approvals. I’m proud that the company I work for has this commitment to addressing the unmet medical needs of patients wherever they are in the world, especially those with conditions currently lacking any viable treatment options and for whom we can potentially provide life-altering solutions.


Motivation
Inspired by Patient-Centricity

My main motivation for work comes from the knowledge that I’m helping people. Occasionally I have been able to meet face-to-face with site staff and study investigators, including key opinion leader physicians, as well as attend industry meetings in order to learn more about the diseases we were targeting, the science around them, and the innovative research being carried out. The ability to learn and grow through new challenges has always been extremely motivating for me.

In clinical research, the patients who take part in our clinical trials as study subjects are not only the people we are trying to help, but they are also an integral part of the work we do. Whether they’re an adult or a child participating with the support of their caregiver, we rely on them to have the courage to join us on this journey through the trial process in the hope of bringing a safe and effective treatment to them and others in need. That service to us is enormous, and it’s a partnership that we take very seriously. We're very grateful for their trust in us—we simply couldn't conduct the trials without them, and we’re doing all we can to try to make the process as patient-friendly as possible.

We’re also privileged to have patient speakers come in and present to us, and most major meetings begin with a video of a patient who has a condition that we are aiming to treat, sharing their inspirational stories. In addition, throughout our buildings, we have many photographs of patients with accompanying testimonials about how they have been helped by the results of our work. All of this combined is a powerful reminder of why we come to work every day.


Cross-team
Collaboration

When I joined Takeda through the integration of Shire, I was struck by the collaborative spirit that ran throughout the company.  Our team was soon forming relationships with our new physician colleagues, who quickly helped us in the development of protocols, sharing information about upcoming interactions with agencies, and offering solutions. All of this was motivated by our shared passion and commitment to helping patients

Quality, Integrity, and Dedication in Service to Others

I always wanted a career that had an altruistic nature to it, and I feel so fortunate to have found it in doing what I do. These are some of the words that inspire and guide me in my daily work.


Alexandra Rossi

Based out of Boston, Alexandra started her pharmaceutical career in 1997 covering various therapeutic areas and holding roles of increasing complexity and responsibility, with experience ranging from Data Management to Monitoring to Clinical Project Management. She is overseeing the clinical trials in Takeda’s expansive Gastroenterology therapy area portfolio.