Senior Clinical Data Manager

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:          Senior Clinical Data Manager

Reports To:       Senior Director, Data Management

Location:            Boston, MA

Position Summary:

Reporting to the Senior Director, Data Management, the Senior Clinical Data Manager will be responsible for establishing and managing the data management function through management/oversight of CRO partners performing data management activities across multiple clinical programs and therapeutic indications. 

What makes this role special:

  • Seek to have a profound impact on young children and their families
  • Potentially be part of the first launch of a medicine for a rare pediatric liver disease
  • Work on a portfolio of multiple potential therapies
  • Gain a rare diversity of commercial experience
  • Develop strategy, as well as manage execution
  • Help shape the culture and future of an emerging biopharma with a big vision
  • Collaborate with a small, collegial team of good people
  • Learn from leadership with deep experience and a history of success
  • Be part of an early biopharma company in an excellent financial position
  • Enjoy great work/life balance, including flex hours, ability to work remotely on Friday’s, generous holiday schedule and business-casual work environment  

Responsibilities (may vary): This description is not intended to provide an all-inclusive listing of duties and responsibilities. Duties may change at the discretion of management, and/or management may request duties be performed that are not listed. This job description is not a contract of employment and does not change your status as an at-will employee.

Key Duties and Responsibilities:

  • Oversee the establishment and maintenance of Data Management plans and study-specific data quality related documents;
  • CRF Development and EDC validation including edit specification development and validation;
  • Provide oversight of external partners (e.g. CDM CROs, central laboratories, ECG core labs, dictionary coding service providers, etc.) to ensure consistency and quality are maintained across projects;
  • Provide oversight of data transfer and/or data integration agreements across external data sources;
  • Ensure that clinical data management activities for clinical trials and regulatory submission projects are completed on time and with excellent quality;
  • Ensure the delivery of clinical trial databases of the highest quality by establishing procedures for ongoing and final data review;
  • Ensure that CDM study files are organized and accessible during study conduct, and that archives are completed after study closeout;
  • Author and review department SOPs, as needed
  • Mentor junior department team members, as needed 

Qualifications:

  • Bachelor’s degree in a scientific, medical or related field; at least 7 years of Lead clinical data management experience, in pharma/biotech
  • Thorough understanding of clinical trials process and regulatory requirements;
  • Thorough understanding of core CDM processes and procedures generally adopted as best practices within the industry, including knowledge of CDM processes with safety laboratory data management and dictionary coding for adverse events and medications;
  • Fully adept at the mechanics of conducting all phases of clinical trial data management within electronic data capture databases from study start up to study close out;
  • Familiar with the regulations that govern CDM activities;
  • Excellent organizational skills and able to adapt to multiple priorities in a fluid environment;
  • Excellent verbal and written communication skills;
  • Excellent skills in validating EDC databases and performing data review;
  • Demonstrated leadership ability and project management skills;
  • Experience managing CROs in data management-related activities;
  • Ability to use PC and widely used software packages, e.g., Excel, MS Word, SAS programming

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.

JOIN ALBIREO

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.