Medical Director, Medical Affairs

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:          Director of Global Medical Affairs Operations

Department:    Clinical

Reports To:       VP and Head of Global Medical Affairs

Location:            Boston, MA

Position Summary:

The Director of Global Medical Affairs Operations will be responsible for overseeing both the strategic and operations aspects of running the Global Medical Affairs organization. The scope of this role is global, supporting multiple therapeutic areas. The Director provides vision, leadership, and mentoring to ensure medical initiatives are successfully implemented according to the medical affairs strategic plan. In addition, the individual is responsible for establishing, reviewing and evaluating business procedures to ensure efficient and effective organizational operation. 

Core responsibilities will include:

  • Develop and manage a first-in-class internal global scientific training program.
  • Monitor and manage the publication and congress plans, ensuring timely submission of data for meetings, manuscripts, posters and presentations and that these efforts stay aligned with the overall strategic plan.
  • Direct the annual strategic planning process to ensure medical projects are aligned with company priorities and resource allocation.
  • Create and distribute periodic reports on medical affairs activities including quarterly reports of progress to goals and medical insights.
  • Ensure departmental contracts and purchase orders are compliantly executed, a system for tracking of project milestones is established and maintained, and the departmental budget is tracked.
  • Develop, implement, and maintain policies and procedures (SOPs) to facilitate and improve efficiency and ensure compliance across the Global Medical Affairs organization. Proactively monitor systems and processes to ensure compliance with company and industry standards. Identify and recommend solutions to problems and/or issues with personnel and/or processes across the department.
  • Monitor and manage the administration of Field Medical Affairs systems (customer relationship management (CRM) software, training portal).
  • Directly develop and supervise the investigator sponsored research program, grants and continuing medical education processes, practices, and systems by strategically overseeing all program related administrative functions and personnel.
  • Arrange and manage relevant global medical affairs team meetings.
  • Oversee and manage the operations for a variety of key external stakeholder events including advisory boards, global steering committee meetings and relevant congress activities.
  • Develop and manage relevant operational aspects for field medical team including event planning, field logistics, certification training, continuing education, and field resource management.
  • Ability to travel regularly as required, region wide and globally as necessary for business needs and development support, to include amongst others; EU Congress planning, support and attendance.. 

Required Qualifications and Experience::

  • Advanced degree in medical science (MD, PhD, or PharmD) preferred
  • Project management experience preferred
  • Bio-pharmaceutical experience in medical affairs
  • Excellent verbal and written communication skills
  • Excellent KOL management and development abilities
  • Ability to travel globally as required
  • Ability to work in a fast-paced, dynamic environment; works well under pressure
  • Applied knowledge of relevant processes and systems including investigator sponsored research, library management systems, CRM systems, grants etc.
  • Possess an understanding of both the pharmaceutical and healthcare industries; understanding of clinical trial design and working knowledge of cGCP guidelines, particularly concerning Investigator Sponsored Research

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.


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.