over 1 year ago
The Senior Medical, Clinical Research will provide direct support as a Subject Matter Expert to various compounds & programs.
Responsibilities include but are not limited to:
- Designing and providing insight of clinical research plans and programs to include the integrated regulatory and biomarker strategies
- Leading the development and execution of the CDP and DDP
- Leading the development of Clinical Protocols to meet CDP objectives
- Reviewing and monitoring safety data from a clinical program and identifying trends and signals
- Developing strategies to identify, monitor and resolve clinical program/trial issues
- MD required, Board Certification in a related area preferred.
- Sr. Medical Director requires: 10+ years in pharmaceutical clinical development
- Working knowledge of the IND/NDA/CTA/MAA processes acquired through direct industry experience
- Knowledge of medical, scientific and clinical research techniques in the Neurology area