Clinical Trial Manager, Emerging Program Team, Oncology

Bluebird Bio, Cambridge, Massachusetts, United States

integrated product platforms with broad therapeutic potential

bluebird bio’s growing Clinical Trial Strategy & Execution (CTSE) team is setting the standard for trial design, conduct, and analysis in gene therapy across multiple therapeutic areas. Join our collaborative, creative and passionate team as we help bring the promise of gene therapy to patients with severe genetic diseases and cancer.

The Emerging Program Team (EPT) is responsible for the development and stewardship of the oncology pipeline by progressing program(s) between candidate selection and Proof of Concept/Registration-enabling study(ies) for internal and external oncology assets. The overall EPT’s primary remit for bluebird bio is as follows:

  • Define program strategy, ensure feasibility
  • Develop and drive investment case at appropriate stage gates (beginning at DC)
  • Integrate cross-functional program plans, resource requirements
  • Communicate program needs to line functions
  • Coordinate cross-functional execution of program strategy post-IND

This is not your typical clinical development operations role and offers you the unique opportunity to be exposed to oncology portfolio strategy and pipeline development – come fly with us! 

Position Overview:

As a member of the EPT clinical team, the CTM will report to the Early Development Lead and be responsible for the day-to-day operational oversight for external SRA programs, including (but not limited to):

  • Provides operational oversight of strategic partners and/or other vendors to ensure the effective execution of the clinical studies on time, with high quality and within agreed budget
  • Primary point of contact for EPT studies to EPT team
  • Primary point of contact for assigned clinical studies for external stakeholders, including principal investigator and site personnel
  • Internal driver for EPT study-level cross functional communications
  • Facilitate/coordinate review and input site contract negotiations
  • Coordinate, schedule, issue minutes for internal EPT clinical meetings
  • Develop/maintain EPT cross functional timelines
  • Set up and maintain central EPT study files and maintain clinical documents centrally
  • Coordinate round table meetings for clinical document development
  • Customize scope of work for each EPT study, create study plans as needed, and outline roles and responsibilities
  • Take approved study concept sheet and coordinate with site as site develops synopsis/protocol (manages timelines, expectations, supports site)
  • Facilitate internal bbb reviews of synopsis and protocol developed by site
  • Develop data to be collected; distribute to clinical team for routine reviews of data
  • Complete study and site level portions for EPT to PT transition plan (when internalizing programs)
  • Drive operational feasibility and site qualification with site personnel
  • Develop site specific execution plan (including risk management)
  • Customize operational feasibility and site qualification plans for each study

Who you are:

  • BS/BA/RN Degree in science or a health-related field; advanced degree is preferred
  • 3-5 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a biotech/pharmaceutical company or contract research organisation
  • Phase I/II Oncology trial management, preferable in both solid tumor and heme. FIH and early development experience required.
  • Must be comfortable working independently and driving activities with sites and vendors, managing interactions with and between internal and external team members
  • Experience with trial and site startup
  • Familiarity with clinical data review and data management processes; Hands-on experience in data cleaning and analysis (including data visualization) recommended
  • Must be able to travel up to 10-15%
  • Strong verbal and written communication skills
  • Excellent interpersonal and organizational skills
  • Ability to deal with competing priorities, strong reasoning, detail oriented and problem-solving ability is essential
  • Ability to work on teams and with multiple projects, and works well under general direction with tight timelines
  • Excellent knowledge of GCP, ICH and FDA regulations
  • “Do-what-it-takes” approach to problem solving.
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

About Bluebird Bio

About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.

Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.