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Clinical Trial Manager

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 Associate Director, Clinical Operations, the Clinical Trial Manager will be responsible for all operational aspects of a clinical trial from study planning activities to study execution and close out, including support for the Global Operations Lead in the management and oversight of the lead phase 3 program.

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.

  • Collaborate with, and manage, the CRO functional teams to deliver on time, within budget and with quality.
  • Support vendor oversight for additional third-party vendors, including laboratories, IXRS, EDC, ePRO and central imaging, as needed.
  • Define and track performance metrics and quality indicators.
  • Maintain and provide information for monthly study status and risks/mitigation strategies (including enrollment curves and timelines) for reporting to senior management.
  • Provide operational input for study documents, such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Study Reference Manual, Pharmacy Manual, Clinical Data Review Plan, Clinical Database specifications development, Clinical Study Report (CSR) development, etc.
  • Contribute to subject recruitment/retention strategy and related initiatives.
  • Manage countries/regions for site activation, CRA and site support during study maintenance, conduct sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP as needed, and support the study close-out and database lock activities.
  • Participate in study data review, and assist with patient narrative writing and other data review activities.
  • Contribute to the TMF set-up, ongoing quality and completeness review, and final reconciliation of study documents, including review of site regulatory documents/packages
  • Serve as an escalation point and resource for internal/external teams and investigational sites; partner with cross-functional groups to achieve deliverables.
  • Ensure that all aspects of GCP compliance and audit readiness are maintained throughout trial conduct.

Qualifications:

  • BA/BS/RN in science or health-related field
  • Minimum 3-5 years clinical trial management experience in biotech/pharma/CRO
  • Working knowledge of GCP, ICH and FDA regulations
  • Strong study management track record showing clear proficiency in clinical project management, including vendor management
  • Experience interfacing with key medical personnel at clinical site(s)
  • Prior monitoring of clinical trial sites
  • Participation in a cross-functional project team
  • Familiarity with clinical data management, DSMB and biostatistics/programming processes preferred
  • Experience in rare/orphan diseases and/or pediatric clinical trials a plus
  • Demonstrated detailed understanding of clinical protocol and intended study populations, as well as solid overall drug development
  • Demonstrated ability to effectively interface with key medical personnel at clinical site(s)
  • Demonstrated ability to flag processes that may not be appropriate for study based on phase, design and/or use of data
  • Ability to travel up to 25% of the time; both domestic and international


Posted
06/11/2021
Type
Full time
Salary Range
$90,000.00 - 160,000.00
per Year
Salary range estimated by
Location
Boston, MA 02298, US