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Start up biotech is searching for a Program Leader to lead project management for the development of in-licensed Phase 0 – 2 therapies and to create legal entities to house those therapies.  The Program Leader will oversee a small cross functional team including vendors to strategically manage Phase I and Phase II development studies.  This is a remote role.  
 

Requirements for the Program Leader:

 

  • BS, MS or PHD in a relevant discipline, eg. science, engineering, biotech.
  • 7+ years experience in early drug development: Phases 0 to II. 
  • Extensive experience working with CROs.
  • Strong project management experience in early drug development. PMP would be a plus.
  • Proven ability to work collaboratively internally and externally, with the ability to manage outside vendors
  • A track record of accomplishment effectively working with senior management
  • The ability to push timetables while keeping the team motivated in a “results oriented” way.
  • Experience in formulations or CMC beneficial
 
 
Responsibilities of the Program Leader:
 
  • Manage early phase clinical development Phase 0 to Phase II
  • Manage the development plan and coordinate all the moving pieces to deliver on execution.
  • Work across all functions to develop timelines and budgets for asset progression, tracking progress, identify risks and any mitigations.
  • Manage the vendor and collaborative partners including contracting and oversight of including contract manufacturers, API and formulation advisors, preclinical CROs and consultants
  • Coordinate and execute asset transfer to new buyer, managing IPO activities and syndication for next phase of development.

 

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