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: Sr. Program Manager
Reports To: Director Program Management
Location: Boston, MA
Reporting to the Director, Program Management, the Sr. Program Manager will be responsible for managing the global cross-functional development teams for two late stage development programs
Project manage and drive cross-functional program team execution for two late-stage clinical development programs.
Build an integrated launch plan for the commercial sub-team for the launch of our late-stage development candidate, odevixibat. Drive execution of this plan supporting the Commercial and Supply Chain sub- teams
Manage program and commercial sub-team meetings, including creating agendas, capturing meeting minutes, ensuring the completion of action items, and tracking deliverables.
Author risk management plan with the development team to identify assumptions, risks, alternative scenarios and facilitate solutions to potential obstacles and challenges.
Drive and report team progress against agreed program goals and timelines.
Ensure effective and transparent communication within teams, across functions, through sub-teams, and to key stakeholders throughout the organization, including senior management
Ensures effective, accurate and timely communication across functional areas within the project / program
Bachelor’s degree and a minimum of 7 years’ experience in a program management role in biotech/pharma industry; Master’s/MBA and a minimum of 5 years’ experience
Deep knowledge and understanding of the commercial launch activities.
Prior experience in identifying critical path activities, risks, and creating contingency plans.
Prior experience in managing a cross-functional project team preferably with late stage to commercialization experience
Excellent communication skills, able to effectively inform key stakeholders and management of the status, issues and solutions.
Proficient with MS Project, SharePoint and PowerPoint
Proven experience in influencing others and bringing teams together to make decisions.
Clinical development and/or regulatory experience with late stage programs (phase 3) and NDA/BLA filings a plus
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.