Director, Clinical Supply Operations

Job Description

Job Title:          Director, Clinical Supply Operations

Reports To:       VP, Pharmaceutical Development

Location:            Boston, MA

Position Summary:

Reporting to the VP, Pharmaceutical Development, the incumbent will be responsible for providing project management and operational oversight of clinical supply activities in support of Albireo’s clinical programs across all phases of development, and ensuring integration of clinical supply plans with clinical development plans. 

Key Duties and Responsibilities:

  • Develop packaging/labelling designs and distribution strategies
  • Coordinate review of label text and proofs 
  • Participate in the selection and qualification of third-party suppliers of clinical supply materials and services
  • Oversee contract packaging, labelling, and distribution operations at third-party service providers
  • Develop and maintain bulk and finished goods forecasts, and schedule production runs as needed to assure accurate and continuous supply to patients while reducing risk and minimizing waste
  • Collaborate with other functions to assure compliance with applicable GxP and global regulatory requirements
  • Support IRT development, including user requirements, supply strategies, and user acceptance testing; oversee ongoing supply activities in the system
  • Represent the Clinical Supply Operations function on compound development and clinical study teams
  • Ensure budget, schedules, and performance requirements are met
  • May hire, mentor, and develop staff according to the future needs of a growing company

Qualifications:

  • Bachelor’s degree in chemistry, pharmaceutics or related discipline within pharmaceutical sciences; Master’s degree preferred
  • A minimum of 10 years’ industry experience in drug development 
  • Strong knowledge of US and EU cGMP requirements and best practices relating to clinical supplies/IMP
  • Strong knowledge of clinical supply planning, packaging, labelling, and distribution
  • Experience in managing multiple third-party contract clinical supply service providers
  • Excellent communication skills, both verbal and written, as demonstrated through prior work experience keeping key stakeholders and management informed of status, issues and recommended solutions
  • Excellent planning and organizational skills
  • Ability to think intuitively and problem solve
  • Prior experience working in a fast pace, small, start-up environment
  • Prior roles requiring the management of multiple and shifting priorities

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.