Sr. Corporate Counsel

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.

Odevixibat has the potential to become the first approved pharmacologic treatment for patients with PFIC. The Company intends to complete regulatory filings in the EU and in the U.S. no later than early 2021, in anticipation of potential regulatory approval, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021, if approved. The Company also plans to initiate a pivotal Phase 3 trial of odevixibat in Alagille syndrome by the end of 2020, and to continue enrolling patients in the BOLD pivotal Phase 3 trial of odevixibat in biliary atresia. Albireo continues to progress its pipeline and expects to complete IND-enabling studies for a new preclinical candidate this year.

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 Corporate Counsel

Reports To:       Chief Legal Officer

Location:            Boston, MA

Overview:

  • Provide high quality, timely and practical legal advice and support, identify and resolve critical legal and business issues arising from regulatory, commercial, clinical, technical operations, and research and development activities.
  • Analyze company activities for compliance with evolving legal and regulatory landscape. Conduct legal research, as needed
  • Advise on the interpretation of legal documents and applicable laws and regulations in a manner that provides practical legal advice while properly managing risk to the organization.
  • Act as the legal representative on cross-functional teams, such as program teams or regulatory, medical and legal review team.
  • Draft and negotiate contracts, including master services agreements, clinical trial agreements, supply agreements, and material transfer agreements.
  • Review presentations, press releases, website materials, brochures, and other company communications (internal and external).
  • Support third party relationship management.
  • Counsel, advise and train internal client team to ensure compliance with applicable laws and regulations and company policies and procedures; and help with general corporate matters.
  • Help with general corporate matters.

Qualifications:

  • Licensed attorney with 5-8 years of experience in the biotechnology/pharmaceutical industry (public company experience strongly preferred).
  • Sound business judgment; strategic and analytical thinking.
  • Self-motivated, flexible and interested in working on a wide range of legal matters in order to understand and advise the company on legal implications of its business strategy.
  • Strong base of knowledge and experience advising clients on laws and regulations governing the biotechnology industry both in and outside the U.S., including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, HIPAA, and product liability laws, and similar laws outside the U.S.
  • Experience working with all levels of management and key business stakeholders with a demonstrated ability to influence outcomes and effectively communicate legal risks to senior management and others.
  • Excellent organizational skills and able to work with a team to meet critical deadlines; flexible and capable of managing multiple projects simultaneously.

Competencies:

  • Attention to details

  • Attracting and developing talent/building a successful team

  • Exceptional time management

  • Effective communication skills (oral and written)

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.