Accountable for the design and execution of the clinical strategy to support the development of a medicine, aligned with the Project Strategy Document (PSD) and the Target Product Profile (TPP)
Job Summary
Accountable for the design and execution of the clinical strategy to support the development of a medicine, aligned with the Project Strategy Document (PSD) and the Target Product Profile (TPP).
Responsible for the timely development and execution of the Clinical Development Plan (CDP) and managing the day-to-day operations of the Clinical Development Team (CDT) in a matrix environment.
Accountable for the clinical & scientific oversight of the assigned program(s), ensuring high quality clinical & scientific standards are met during all aspects of the program.
Matching Summary
Accountable for the design and execution of the clinical strategy to support the development of a medicine, aligned with the Project Strategy Document (PSD) and the Target Product Profile (TPP).
Salary
Base: $338,000 - $400,000; Bonus/Equity: Incentive compensation and equity may be included; Benefits: Not specified
Skills & Requirements
Must-have
Clinical strategy design and execution
Clinical Development Team leadership
GCP and ICH regulations adherence
Clinical and scientific oversight
Regulatory submission authorship
Nice-to-have
Agile team collaboration
Patient impact focus
Dynamic biotech ecosystems
Key Requirements
MD - Board Certified in Pulmonology preferred
5+ years clinical development experience
Working knowledge of pharmaceutical development processes