Director, Clinical Quality Assurance

Company Information

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.

Albireo are developing odevixibat initially to treat patients with PFIC, a rare genetic liver disease, and plan to consider additional development in other paediatric cholestatic liver diseases and disorders in the future. Their Phase 3 program in PFIC includes a single randomized, double-blind, placebo-controlled, multicentre clinical trial and an open-label long-term extension study. The double-blind trial, called PEDFIC1, is underway with data read out anticipated in the Middle of 2020. (June/July).

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 Description

Job Title:          Director, Clinical Quality Assurance

Reports To:       Director of Quality Assurance

Location:            Boston, MA

Position Summary:

The Director of Clinical Quality plays a lead role in the development of the operational strategy to ensure clinical studies are conducted in a compliant manner and data integrity is maintained.  The Director leads and facilitates operational and continuous improvement of Albireo’s Clinical Quality systems. The Director will create a strategic oversight plan, develop standards, create processes and work with Clinical Operations and Contract Research Organizations (CRO) to establish efficient risk-based quality systems that allow fast and flexible compliant development activities.

The Director will additionally assist in monitoring adherence to regulatory requirements (ICH, FDA, EMA, etc.) and GCP guidelines. He/She leads efforts to identify potential compliance and operational risks to Albireo clinical trials and facilitate the development of mitigation strategies with the assistance of Clinical Development and QA personnel.  The goal is to assure the high quality of our operations and services aiming to the long-term success of our business.

Key Duties and Responsibilities:

  • Serve as subject matter expert concerning GCP and provide compliance guidance to internal personnel within Clinical and Quality departments
  • Establish efficient vendor and site oversight operations to ensure a continuous awareness of the state of compliance for each study
  • Lead the development of operational strategies to ensure the creation of flexible policies and procedures related to clinical research oversight and compliance, with a focus on efficiency and speed
  • Lead efforts to include adequate quality elements into each study plan provided by the CRO partner to ensure adequate quality oversight
  • Partner cross functionally with Clinical Operation and CRO subject matter experts to evaluate areas for process improvements
  • Collaborate cross functionally to ensure the implementation of required procedures, best practices and adherence regulatory requirements, and GCP guidelines
  • Develop and deliver relevant training to Albireo Clinical Development staff, for example annual GCP training, SOP training, etc.
  • Manage strategic/compliance risk assessments, evaluate metric reporting, and facilitate root cause analysis and CAPA process implementation and effectiveness checks
  • Liaise with Clinical Development, CRO, and Clinical sites to conduct and support GCP audit and inspection activities, and maintain a state of ongoing inspection readiness
  • Mentor and manage staff, contractors, and/or consultants
  • Ensure Albireo Clinical Study departments have annual GCP training. 

Minimum Education, Experience, Knowledge and Skills Required:

  • Bachelor’s degree required
  • At least 6-8 years’ experience in Clinical Development and/or, Clinical Quality Assurance/Compliance function within the pharmaceutical/biotech industry
  • Extensive knowledge of FDA / global clinical trial regulations and ICH E6(R2) GCP Guidelines
  • Understanding of the clinical development process and documentation requirements
  • Proactive approach to GCP compliance
  • Knowledge of outsourced models of clinical research conduct and associated sponsor requirements
  • Knowledge of site and vendor auditing processes and recent FDA and EMA compliance landscape
  • Ability to work independently with minimal direction.

Albireo Values:
Partnership & Commitment
We believe that people and relationships ultimately determine success. We are committed to achieving excellence in everything we do. We strive to identify, attract and develop the best talent for our business, focusing on execution and teamwork.

Enjoyment & Creativity
We encourage individual creativity but believe that team effort produces the best results. We promote opportunities to contribute, providing a positive environment of curiosity and development. In the rapidly changing world of drug development, we work to anticipate changes and develop innovative approaches to meeting our goals.

Mutual Trust & Respect
We value diversity and strive to provide an inviting and inclusive environment. We seek to inspire trust and respect by taking responsibility for our actions, maintaining high ethical standards and encouraging collaboration and honest and straightforward communication.


Equal Opportunity Employer

Albireo Pharma, Inc. is an equal opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

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.  Albireo is not responsible for any fees related to resumes that are unsolicited.