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.