The Executive Director, GPTL is responsible for providing strategic direction and leading the global drug development for one or multiple Global Program Teams with complex Phase III clinical development programs
Job Summary
The Executive Director, GPTL is responsible for providing strategic direction and leading the global drug development for one or multiple Global Program Teams with complex Phase III clinical development programs.
The GPTL is accountable for Program ownership with final accountability for clear definitions of program goals, plans, decisions and deliverables to meet those goals.
The duties of this role are generally conducted in an office environment.
Matching Summary
The Executive Director, GPTL is responsible for providing strategic direction and leading the global drug development for one or multiple Global Program Teams with complex Phase III clinical development programs.
Skills & Requirements
Must-have
Global drug development strategy
Lead Global Program Teams
Phase III clinical development programs
Regulatory filings (BLA/NDA/MAA)
Risk identification and mitigation
Nice-to-have
Stimulate creative and productive discussion
Builds alliance within the organization
Tenacity to weather short-term setbacks
Key Requirements
Advanced life-science degree (MD, PhD or PharmD) preferable
Minimum of ten (10) years of experience in drug development
Experience leading development of at least one development candidate
Experience leading drug development projects in a matrixed, global organization
Experience leading preparation of PMDA/EMA/FDA milestone meetings