Posted

4 days ago

Location

Cambridge, MA

Description

Sr Director, Clinical Development

My client is expanding and seeks a Sr Director, Clinical Development to take on the following tasks:

  • Direct clinical trials throughout the clinical trial design, ensuring timely execution and completion of the studies and providing medical, regulatory, and technical guidance throughout the process.
  • Draft and manage clinical content of all clinical and regulatory documents, ensuring effective technical review of clinical plans and protocols.
  • Offer clinical perspective on research and development programs and potential in-licensed programs.
  • Provide strategic leadership for programs that integrate the extensive knowledge in clinical research with the latest knowledge from the medical community.
  • Ensure compliance with all relevant external guidelines and regulations.
  • Liaise with partners across the medical and scientific communities, facilitate coordination, foster collaboration, and develop and maintain a perspective of the evolving science and clinical research landscape.

 

The ideal candidate will possess the following qualities:

  • MD or MD/PhD with substantial industrial experience in design, execution, and interpretation of early development and late-stage clinical trials.
  • 3+ years industrial clinical experience designing and executing clinical trials with expertise in renal or internal medicine experience.
  • Thorough understanding of clinical study design principles and all phases of industrial drug development.
  • Knowledge of regulatory requirements and good clinical practices.
  • Track record of planning and conducting clinical trials and delivering high quality results within established timelines.
  • Ability to interpret, analyze, and communicate data, and generate clinical and scientific documents.
  • Experience partnering with external collaborators in support of internal clinical and regulatory matters.
Title and salary are commensurate with experience.