Associate Director/Director Clinical Operations

Job Description

Job Title:             Associate Director/Director Clinical Operations

Reports To:          Vice President Clinical Operations

Location:               Boston, MA

Position Summary:

Reporting to the Vice President, Clinical Operations, the Associate Director/Director Clinical Operations will be responsible for managing the global phase 3 clinical trial(s) in support of the lead asset A4250 in rare pediatric cholestatic liver diseases.

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:

  • Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution
  • Develop and manage clinical trial risk and mitigation plans to ensure delivery to timelines, budget and quality.
  • Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
  • Co-monitor or monitor studies if needed for the program
  • Author, review and manage cross functional review of clinical protocols, clinical trial documents including informed consent forms, study plans and manuals, and clinical study reports.
  • Review development of clinical sections of trial and program level regulatory documents and submissions (such as IBs, briefing packages, responses to Health authorities, INDs, CTAs, NDAs, MAAs)
  • Represent Clinical Operations in cross-functional teams, clinical meetings, and regulatory meetings. Provide regular status updates to senior management.
  • Manage and provide oversight of all operational aspects of clinical trial activities from study start-up through database lock, ensuring GCPs and relevant SOPs are met
  • Manage study-related vendors and serving as the primary point of contact for CROs, study staff and contract labs
  • Author and review department SOPs, as needed
  • Mentor junior department team members

Qualifications:

  • Bachelor’s degree and a minimum of 10 years’ experience in clinical operations and 5 as the lead for global clinical studies in biotech/pharma/CRO.
  • Deep knowledge and understanding of the drug development activities from pre-IND through NDA including ICH, GCP, and global regulations.
  • Extensive experience managing clinical programs, CROs, budgets, and timelines required
  • Strong working knowledge of MS Project and developing Gantt charts
  • Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required
  • Ability to organize and manage multiple priorities required
  • Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues
  • Maximum flexibility to adapt to changing program needs in real time
  • Strong leadership skills and self-awareness
  • Excellent communication skills, able to effectively inform key stakeholders and management of the status, issues and solutions.
  • Ability to travel 10-20% of the time, both domestic and internationally

 

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.