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: Associate Director of Medical Information & Operations
Reports To: Director of Global Medical Affairs
Location: Boston, MA
The Associate Director of Medical Information & Operations will be responsible for overseeing the medical information and operations aspects of the Global Medical Affairs organization. The scope of this role is global, supporting multiple therapeutic areas. The Associate Director is responsible for day-to-day administration of medical information (MI) including manning the MI mailbox, coordinating with the vendor global call center, creating SRLs (including custom responses), tracking and timely reporting of MI info. Acts as coordinator for Veeva submissions for review of medical affairs materials, coordinator for grant requests, tracks ISR studies and tracks global medical affairs plan to budget. Chief point of contact for contracts, SOWs, POs for Medical Affairs. Responsible for meeting logistics (internal and external) as well as performing FMV calculations for the company.
Core responsibilities will include:
Required Qualifications and Experience:
Advanced degree in medical science (BS, MS) preferred
Project management experience preferred
Bio-pharmaceutical experience in medical affairs
Excellent verbal and written communication skills
Ability to travel globally as required
Ability to work in a fast-paced, dynamic environment; works well under pressure
Applied knowledge of relevant processes and systems including investigator sponsored research, medical information, Veeva, grants etc.
Possess an understanding of both the pharmaceutical and healthcare industries; understanding of clinical trial design and working knowledge of cGCP guidelines, particularly concerning Investigator Sponsored Research
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.