Senior Associate Regulatory Operations
Company: Albireo Pharma, Inc.
Location: Boston
Posted on: April 10, 2021
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Job Description:
Albireo Pharma Overview: Albireo is a clinical-stage
biopharmaceutical company focused on the development and potential
commercialization of novel bile acid modulators to treat orphan
pediatric liver diseases and other liver or gastrointestinal
diseases and disorders. Albireo has deep expertise in bile acid
biology and a pipeline of clinical and nonclinical programs.The
company's first commercial launch will be Odevixibat, which is a
potent and selective inhibitor of the ileal bile acid transporter
(IBAT), sometimes referred to as the apical sodium dependent bile
acid transporter (ASBT), that has minimal systemic exposure at
therapeutic doses and acts locally in the gut. Albireo is
developing Odevixibat initially to treat patients with PFIC, a rare
genetic liver disease, and plans to consider additional development
in other pediatric cholestatic liver diseases and disorders in the
future. Our Phase 3 program in PFIC includes a single randomized,
double-blind, placebo controlled, multicenter clinical trial and an
open-label long-term extension study. The double-blind trial,
called PEDFIC1, is underway with data read out anticipated in mid-
2020. The U.S. Food and Drug Administration (FDA) has granted to
the Odevixibat PFIC program or elements of its fast track, rare
pediatric disease and orphan drug designations. The European
Medicines Agency (EMA) has granted Odevixibat orphan designation,
as well as access to the Priority Medicine's (PRIME) scheme for the
treatment of PFIC. Its Pediatric Committee has agreed to Albireo's
Odevixibat Pediatric Investigation Plan for PFIC. Both FDA and EMA
also have granted orphan drug designation to Odevixibat for the
treatment of Alagille syndrome and primary biliary cholangitis.
Albireo will commercialize Odevixibat in the US, Europe & Canada
and is pursuing potential partners in remaining regions.Position
Summary: We are seeking an experienced, in-house Regulatory
Operations professional who can assist with a variety of
submissions and records management activities with limited
supervision. In this position, you will participate in various
activities as part of a dynamic and evolving Regulatory Operations
team. The Senior Associate must be a creative, resourceful,
integrative thinker. Roles and Responsibilities
Preferred Experience:
Qualifications:
Keywords: Albireo Pharma, Inc., Boston , Senior Associate Regulatory Operations, Other , Boston, Massachusetts
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