Medical Director – Clinical Development – Ophthalmology
| Company | Regeneron Pharmaceuticals |
|---|---|
| Location | Tarrytown, NY, USA |
| Salary | $280700 – $379900 |
| Type | Full-Time |
| Degrees | MD |
| Experience Level | Senior |
Requirements
- An M.D. or equivalent with board eligibility or board certification in Ophthalmology
- At least 2 years pharmaceutical industry experience (equivalent research in academia may be considered)
- Experience in Ophthalmic drug development strongly preferred
- Previous interactions with regulatory agencies or common technical document (CTD or “dossier”) submission in an ICH region is an advantage
Responsibilities
- Acts as medical expert and leader in interactions with external stakeholders
- Defines clinical trial-related Clinical Development Program (CDP) goals and objectives
- Works closely with discovery teams to provide input on the next generation of targets in the field
- Responsible for the relevance and accuracy of medical science underpinning of clinical study concepts (CSC) based on thorough scientific review and consultation with internal and external experts
- Reviews and finalizes clinical study concepts for presentation to Therapeutic Head, Strategic Program Teams, and internal governance meetings
- Leads the Global Clinical Study Team to produce high quality program deliverables on schedule
- Responsible for the medical content of clinical study reports, the analysis of clinical data, including safety monitoring, and all activities and procedures that ensure patient safety
Preferred Qualifications
- Experience in Ophthalmic drug development strongly preferred
- Previous interactions with regulatory agencies or common technical document (CTD or “dossier”) submission in an ICH region is an advantage