Senior Manager Clinical Data Management

Albireo Pharma Overview: Albireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases.

Albireo has deep expertise in bile acid biology and a pipeline of clinical and pre-clinical programs.

Albireo’s lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases with Phase 3 pivotal trials in PFIC, Alagille syndrome and biliary atresia.

The Company completed IND-enabling studies for new preclinical candidate A3907 and plans to advance development in adult liver disease.

Albireo was spun out from AstraZeneca in 2008 and is headquartered in Boston, Massachusetts, with its key operating subsidiary in Gothenburg, Sweden.

The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year.

The company’s first commercial launch will be odevixibat, which is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia and Alagille syndrome.

A potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi), odevixibat acts locally in the small intestine.

Odevixibat has the potential to become the first approved pharmacologic treatment for patients with PFIC.

The FDA has granted Priority Review and set a Prescription Drug User Fee Act (PDUFA) goal date of July 20, 2021.

Odevixibat previously received Fast Track, Rare Pediatric Disease and Orphan Drug Designations in the U.S.

In Europe, the Company has submitted odevixibat for a Marketing Authorization Application (MAA) to the EMA seeking approval in PFIC.

Odevixibat is the only IBATi granted accelerated assessment by the EMA.

It has also been granted Orphan Designation, as well as access to the PRIority MEdicines (PRIME) scheme for the treatment of PFIC.

The EMA’s Pediatric Committee has agreed to Albireo’s odevixibat Pediatric Investigation Plans for PFIC and biliary atresia.

In addition to PFIC, odevixibat has Orphan Drug Designations for the treatment of ALGS, biliary atresia and PBC.

With U.S.

and EU regulatory filings in PFIC completed, the Company anticipates potential regulatory approvals, issuance of a rare pediatric disease Priority Review Voucher and launch in the second half of 2021.

Odevixibat is also currently being evaluated in a Phase 3, long-term extension study and two pivotal Phase 3 trials: the ongoing PEDFIC 2 Phase 3 open-label trial in patients with PFIC, the BOLD Phase 3 trial in patients with biliary atresia and the ASSERT Phase 3 trial in ALGS.

Albireo is also exploring multiple methods for modulating bile acids to significantly change the bile acid transporter approach in adult liver disease, with two promising new candidates with two different mechanisms of action.

The Company will initially focus on primary sclerosing cholangitis (PSC) and primary bilateral cholangitis (PBC) as well as viral cholestatic liver disease, including hepatitis B and D.

Position Summary: Reporting to the Senior Director, Data Management, the Senior Manager will be responsible for establishing and managing study data management activities 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 across all data systems (e.g.

EDC, IXRS, lab, eCOA, etc.); CRF Development and EDC validation including edit specification development and validation and User Acceptance Testing across all data systems.

Serves as the DM focal point on assigned studies for all local interfaces and preserves a fluent workflow with the other interfacing departments and local procedures and processes 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; Manage the Albireo team data review and ensure all data issues are resolved per expectations for the delivery of clinical trial databases of the highest quality.

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 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