Director, Data Management

Company Information

Imagine your child scratching herself so unstoppably through the night that she wakes with blood-stained sheets. Nothing soothes her. You haven’t slept through the night in years. At school, unable to focus, she takes off her shoes and socks to scratch her feet on the carpet. The itch is inescapable. She has a life-threatening liver disease, and it’s getting worse. 

Now imagine that you work for a company with a chance to help this child and her family.

This is Albireo. We are relentlessly focused on liver disease with the belief that bile acid modulation offers an innovative way to treat numerous rare and more common diseases affecting people worldwide. We are building a collaborative, committed, employee-friendly company, as we work to make this vision a reality.

Albireo is a clinical-stage biopharmaceutical company focused on the development and potential commercialization of novel bile acid modulators to treat orphan pediatric liver diseases, and other liver or gastrointestinal diseases and disorders. We have deep expertise in bile acid biology, and a pipeline of clinical and preclinical programs. Our parent company, Albireo Pharma, Inc., is located in Boston, Massachusetts, and our key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. We were spun out from AstraZeneca in 2008. The Boston Business Journal named Albireo one of the 2019 Best Places to Work in Massachusetts.

This is an exciting and pivotal time at Albireo. Our lead product candidate is in a Phase 3 clinical trial for a rare, life-threatening pediatric liver disease with no approved pharmacologic treatment option. We expect topline results in mid-2020. Meanwhile, we are advancing our pipeline in other disease indications. We have a licensing agreement in Japan that already has generated revenues, an excellent financial position for a pre-launch company and a small team of great people. We know personally many of the people we’re working to help, and they motivate us every day.

Job Description

Job Title:          Director, Data Management

Reports To:       Vice President, Clinical Operations

Location:            Boston, MA

Position Summary:

Reporting to the Vice President, Clinical Operations, the Director, Data Management will be responsible for establishing and managing the data management function through management of existing CRO partners performing data management activities across multiple 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:

  • Manages relationships and establishes partnerships with CROs, vendors, and other external partners including strategic partnerships and preferred provider relationships, and participation in CRO/vendor selection for Data Management services and software.
  • Oversight of data management vendors with respect to key performance indicators, metrics, and program level deliverables and timelines.
  • Oversight of CRF Development and build, validation, and maintenance of clinical trial databases in accordance with ICH/GCP guidelines and current regulatory requirements.
  • Oversee the establishment and maintenance of Data Management plans and study-specific data quality related documents;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;
  • Develop and oversee data visualization and review tools;
  • Ensure that CDM study files are organized and accessible during study conduct, and that archives are completed after study closeout;
  • Contribute to back-end project budget/resource planning, forecasting, program milestones, along with Clinical Operations management.
  • Author and review department SOPs, as needed
  • Supervise and/or Mentor junior department team members 

Qualifications:

  • Bachelor’s degree in a scientific, medical, Computer Systems/IT Background or related field; at least 10 years of experience in clinical data management, in pharma/biotech preferred
  • Thorough understanding of clinical trials process and regulatory requirements;
  • Advanced Experience managing CROs in data management-related activities;
  • Advanced knowledge of GCP/ICH standards, 21 CFR Part 11, CDISC 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;
  • Advanced knowledge of 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;
  • Ability to use PC and widely used software packages, e.g., Excel, MS Word, SAS programming

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.