Kristen Clare, Ms, Rac
About Kristen Clare, Ms, Rac
Kristen Clare is the Director of Regulatory Affairs at Alkermes in Waltham, Massachusetts, with extensive experience in regulatory affairs across multiple therapeutic areas.
Title
Kristen Clare is the Director of Regulatory Affairs at Alkermes, based in Waltham, Massachusetts, United States.
Current Company
Kristen Clare currently works at Alkermes, where she leads the regulatory affairs department. Her role involves developing and executing global regulatory strategies, primarily focused on supporting early development programs.
Previous Experience at Takeda
Kristen Clare has extensive experience at Takeda, having held several positions. From 2019 to 2020, she was the Associate Director and Global Regulatory Lead. Prior to that, she served as a Manager in Global Regulatory Affairs Strategy from 2012 to 2014 and as a Project Associate in Drug Development Management from 2014 to 2015, all based in Cambridge, Massachusetts.
Previous Positions at Shire
At Shire, Kristen Clare held multiple roles, including Associate Director and Global Regulatory Lead from 2018 to 2019, Associate Director and Global Regulatory Project Manager from 2017 to 2018, and Manager of US Regulatory Strategy from 2015 to 2017. Her roles were primarily focused on regulatory affairs in Cambridge, Massachusetts.
Educational Background
Kristen Clare holds a Master of Science (MS) from Northeastern University, achieved between 2010 and 2012. Additionally, she earned a Certificate in Organizational Leadership from Villanova University from 2020 to 2021. She completed her Bachelor of Science at Roanoke College from 2006 to 2010 and obtained her High School Diploma from Conestoga Senior High School from 2002 to 2006.
Expertise and Skills
Kristen Clare has extensive experience in regulatory affairs, having worked across various therapeutic areas such as lysosomal storage diseases, ophthalmology, neurology, oncology, immunology, biologics/small molecules, orphan drugs, and pediatrics. She possesses strong technical and scientific documentation skills, effective presentation skills, and thorough knowledge of the drug development process. Kristen is adept at interpreting US and international regulatory guidance.