We recently had the pleasure of interviewing Asli Santos, PharmD, RAC from our newest partner company, Moderna. Dr. Santos is the Senior Director, Oncology Strategy Lead of the Regulatory Sciences team, and is also serving as the Head of PharmD Fellowship Programs at Moderna. Read on to learn more about our newest program, Global Regulatory Science, as well as Dr. Santos’ career and what inspired her to start a fellowship program with MCPHS.

Can you tell us a bit about yourself?

I was born in Iowa City, Iowa and lived in Turkey from the age of 3 to 9. My family subsequently moved to Auburn, Alabama where I stayed until I finished pharmacy school. Having parents who had the courage to uproot themselves far away from home gave me the adventurous spirit to explore new places as well: first when I was in pharmacy school (during which I took time off to study French in Paris) and later in my career when I sought to work internationally. I have always been drawn to different cultures and languages and learning about all aspects of humanity. In addition to having a strong passion for science (I’m one of those people who geek out listening to Advisory Committees and Immunology courses), I’m also very drawn to topics like organizational psychology, leadership and belonging. When I’m not working, I am often listening/reading about these topics, with Brené Brown being one of my favorite authors/teachers of all time.

Can you tell us about your professional journey and how you got to your current position at Moderna?

After obtaining my Doctor of Pharmacy Degree from Auburn University School of Pharmacy in 1999, I pursued a Rutgers/Novartis PharmD fellowship in Clinical Research and Development. After my first year of fellowship, I leveraged the flexibility of the program to organize a 3-month rotation at the Novartis affiliate in Istanbul, Turkey. Since I was able to read, write and speak Turkish, I quickly got involved in many interesting projects including writing a report on drug registration procedures in Turkey. That experience sparked a growing interest in seeking an industry job outside the U.S. and learning more about regulatory affairs, full of its unique challenges and nuances linked to country specificities.

After my fellowship, I was able to secure a permanent position as Senior Clinical Research Scientist at Novartis U.S. and thoroughly enjoyed gaining a deeper knowledge of clinical development. In 2002 I decided to pursue more seriously my desire to work abroad and it took me a solid year of persistence, hope, many rejection letters and some luck (the topic of another interview, perhaps) before I obtained the job of my dreams working in regulatory affairs at Sanofi in France. After a truly enriching 6 years of professional growth working with Sanofi affiliates in 36 countries and supervising a team of senior regulatory managers, I returned to the US in 2009. I began working for a small company in Atlanta, Georgia (named Sciele at the time) on both clinical and CMC regulatory strategies.

Subsequently, as a regulatory consultant for Novartis for 4 years, I held the role of Global Program Regulatory Director and contributed to preparations of several meetings with Heath Authorities and diverse submissions worldwide. Subsequently, I led global regulatory teams for both early development and late stage Oncology programs at AbbVie for 5 years. In July 2020, I seized an opportunity to join Moderna and expand my scope of responsibilities as the lead regulatory strategist for the Oncology therapeutic area within Global Regulatory Science led by Charbel Haber. I am truly grateful for my professional journey thus far, which has led me to an organization that works tirelessly on cutting-edge science to treat difficult diseases.

Can you tell us about Moderna?

Moderna is a very dynamic company with core values that include being bold, collaborative, curious and relentless, in addition to our “base camp” values of quality, integrity, and respect. We have several “Moderna Mindsets” (such as acting with urgency, questioning convention, obsessing over learning, pushing past possible and other key mindsets) that are foundational elements of our organization. Thanks to amazing people and these company values and mindsets, Moderna has achieved unprecedentedly rapid regulatory approvals worldwide for the COVID-19 vaccine while building strong partnerships with global regulators.

You can read more about Moderna at the company website here.

Can you tell us about the new Global Regulatory Science fellowship being offered in collaboration with MCPHS?

Moderna, in collaboration with MCPHS, offers a unique opportunity for PharmD graduates to gain rapid experience in the pharmaceutical industry with a focus on Regulatory Science while working on diverse projects to deepen their understanding of product development.  Moderna will launch the fellowship program with 1 fellow starting in July 2022. The fellow will join the Global Regulatory Science team, in Cambridge, Massachusetts. 

During the 2-year fellowship, the fellow will focus on Regulatory Strategy and take part in projects covering 2-3 regulatory specialties, including:

  • Regulatory Advertising and Promotion
  • Regulatory Labeling
  • Regulatory Policy
  • Regulatory Operations
  • Regulatory CMC
  • International Regulatory Affairs

The fellow will be able to work directly with several experienced regulatory professionals in multiple specialties and across multiple therapeutic areas.  Projects will be assigned based on the fellow’s areas of interest and available opportunities to build the fellow’s competencies as a regulatory professional.  Additionally, the fellow will have the option to take part in a 1-3 month rotation in another department outside of Global Regulatory Science at Moderna.

Why did you decide to start a fellowship and what are you most excited about?

From a company perspective, Moderna, in collaboration with MCPHS, is seeking this unique postdoctoral fellowship program to expose qualified Doctor of Pharmacy graduates to the biopharmaceutical industry, and to enhance the role of pharmacists within this field.

From my own personal perspective, it has always been a dream (in addition to my world travels) to start a PharmD fellowship at a new company. My career trajectory was transformed thanks to the amazing opportunities that a PharmD fellowship provided me and this is my way of “paying it forward”. What I’m most excited about is working with future fellows, alongside my Moderna and MCPHS colleagues, to help fellows gain the skills and diverse experiences they need to become strong regulatory professionals.

Asli Santos, PharmD, RAC

Interested in a fellowship with MCPHS and Moderna or one of our other partner companies? Our application portal is open now through November 19, 2021! Applications are viewed and interviews are scheduled on a rolling basis – apply early! Check out the Company Brochures tab for more info.

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