Director - Early Clinical Drug Development
Start up biotech is searching for a Director to lead project management for the development of in-licensed Phase I/II therapies and to create legal entities to house those therapies. The Project Director will oversee a small cross functional team including vendors to strategically manage Phase I and Phase II development studies.
Requirements for the Director:
- BS, MS or PHD in a relevant discipline, eg. science, engineering, biotech.
- 5+ years experience in early drug development: Phase I and Phase II
- Strong Project Management experience in early drug development. PMP would be a plus.
- Strong track record of accomplishment effectively working with senior management
- Proven ability to work collaboratively internally and externally, with the ability to manage outside vendors
- The ability to push timetables while keeping the team motivated in a "results oriented" way.
- Experience in formulations or CMC beneficial
Responsibilities of the Director:
- Manage early phase clinical development Phase I and Phase II
- Manage the development plan and coordinate all the moving pieces to deliver on execution.
- Work across 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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