The Medical Director/Sr. Medical Director will lead and help take ownership of one or more of our progressing clinical trials while providing strategic direction, leadership and medical expertise to our growing clinical development team. This role provides the opportunity for the right candidate with superior protocol writing, medical monitoring and KOL interaction skills and experience with the opportunity to truly make an impact on the lives of patients and future success at Corbus. This position works as the project team lead.
- Provide leadership and medical expertise to Company’s clinical development programs including phase 3 studies
- Build effective relationships with site investigators and KOL’s
- Lead safety surveillance, risk management and risk communication activities including medical reporting and assessment of adverse events
- Develop risk management profiles
- Write protocols while working closely with CMO
- Review and provide medical/safety input of PBRER, DSUR, clinical expert statement, etc.
- Develop and direct overall drug safety operations processes to insure compliance with regulatory requirements U.S. and EMEA
- Effectively communicate with clinical operations/development staff, project management, IT, clinical QA, legal and other internal and external (CRO) staff and support
- Thorough understanding of medical coding (MEDRA)
- Support regulatory submissions including NDA