Alison Blaus
About Alison Blaus
Alison Blaus is a Director at Bristol Myers Squibb and Vice President at Nkarta, Inc., with extensive experience in regulatory affairs across multiple pharmaceutical companies.
Current Roles at Nkarta, Inc. and Bristol Myers Squibb
Alison Blaus is currently serving as Vice President at Nkarta, Inc. in the United States. Simultaneously, she holds the position of Director at Bristol Myers Squibb in Summit, New Jersey, United States. Her responsibilities involve extensive regulatory affairs management and strategic initiatives across both roles, contributing significantly to each company's operational capabilities.
Previous Positions at Kite Pharma and Gilead Sciences
Before her current engagements, Alison Blaus held notable positions at Kite Pharma and Gilead Sciences. At Kite Pharma, she progressed from Associate Director of Regulatory Affairs to Director, working from 2018 to 2020 in Santa Monica, California. Her role included regulatory strategies and overseeing submissions for investigational therapies. At Gilead Sciences, she served as the Global Regulatory Product Lead, Associate Director, from 2016 to 2018, managing global regulatory submissions and product strategies in Foster City, CA.
Experience at FDA, Pfizer, and Johnson & Johnson
Alison Blaus has an extensive background in regulatory affairs and project management, with previous roles at the FDA, Pfizer, and Johnson & Johnson. At the FDA, she was a Senior Regulatory Health Project Manager from 2008 to 2016 in the Washington D.C. Metro Area. Prior to that, she worked at Pfizer as a Regulatory Documents Author from 2005 to 2008 and at Johnson & Johnson as a Clinical Data Coordinator from 2003 to 2005.
Educational Background in Neuroscience
Alison Blaus pursued her undergraduate education at the University of Delaware, where she obtained a Bachelor of Science in Neuroscience from 1995 to 1999. Her academic foundation in neuroscience has informed her subsequent career in regulatory affairs and health project management, contributing to her deep understanding of medical and scientific regulations.
Regulatory Leadership in CAR T Therapies
As a Global Regulatory Lead, Alison Blaus oversees regulatory strategies for late-stage and early-stage investigational CAR T therapies targeting B-cell malignancies. She manages complex regulatory submissions such as Breakthrough Therapy Designation (BTD) and PRIME applications. Her role also includes leading Regulatory Project Teams and developing negotiation strategies with regulatory authorities.