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.
Odevixibat has the potential to become the first approved pharmacologic treatment for patients with PFIC. The Company intends to complete regulatory filings in the EU and in the U.S. no later than early 2021, in anticipation of potential regulatory approval, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021, if approved. The Company also plans to initiate a pivotal Phase 3 trial of odevixibat in Alagille syndrome by the end of 2020, and to continue enrolling patients in the BOLD pivotal Phase 3 trial of odevixibat in biliary atresia. Albireo continues to progress its pipeline and expects to complete IND-enabling studies for a new preclinical candidate this year.
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.
Reports To: Senior Director Global MSL Lead
Location: West Coast
Position Summary: The Medical Science Liaison is a field-based scientific and clinical expert who strategically supports Albireo’s medical and scientific objectives. The MSL is responsible for identifying, developing and managing peer-to-peer relationships with a variety of healthcare professionals including pediatric hepatologists, gastroenterologists and surgeons.
He/she will be accountable to engage in high quality communications regarding the science and clinical applications of portfolio to variety of external stakeholders, as well as obtain important insights about current practice, treatment landscapes, and emerging clinical and scientific data. In addition, the MSL is expected to build strong cross-functional relationships, as well as provide meaningful subject-matter experts, to other colleagues at Albireo, in a fully compliant manner.
Key Duties and Responsibilities:
Tagged as: United States
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