Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan paediatric liver diseases and other liver or gastrointestinal diseases and disorders. We have deep expertise in bile acid biology and a pipeline of clinical and nonclinical programs.
Odevixibat is a potent and selective inhibitor of the ileal bile acid transporter (IBAT), sometimes also 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 it fast track, rare paediatric disease and orphan drug designations. The European Medicines Agency (EMA) has granted odevixibat orphan designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC. Its Paediatric 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 commercialise Odevixibat in the US, Europe & Canada and will partner in remaining regions.
Job Title: Medical Director Germany / DACH
Reports To: VP Head of Medical Affairs Europe
Location: Europe (Germany preferred)
The Medical Director Germany / DACH will work as the designated medical lead for Germany (to expand to DACH in future), offering aligned direction and implementation, working alongside the EU Medical VP and the rest of the EU and US medical team.
The Medical Director Germany / DACH will collaborate with and actively support the VP of Medical Europe for the onward execution of the medical strategy in Germany and provide strategic input relevant to Germany and Europe, based on their local expertise and insights.
The Medical Director Germany / DACH will be a key role in the ongoing build out of the wider planned EU medical affairs team.
The role will be equally customer facing and strategic with the Medical Director responsible for the roll out, implementation and execution of the devised medical launch strategy for Odevixibat (PFIC) in Germany and any associated launches beyond this. The role will potentially expand to the DACH region (Austria and Switzerland).
Core responsibilities include:
Support the relative clinical operations team for clinical trial support. Responsibilities to include site visits and recruiting as required across Germany and DACH
Required Qualifications and Experience:
Equal Opportunity Employer
All applicants should be legally entitled to work for any employer in the U.S.
Note to employment agencies: Please do not forward any agency resumes.