Senior Medical Manager
Clinical Research Department / Oncology & Radiopharmaceuticals Department
- Led or supported clinical development across 9 assets, including one Class 1 innovative drug and three Class 2 improved drugs.
- Owned one NDA, one pre-NDA, and one ANDA submission.
- Led or supported 4 studies across 3 assets into pivotal Phase III development, and led two Phase II and one Phase I studies.
- Completed two on-site CDE inspections.
- Supported CDE communications across multiple programs, including confirmatory clinical design and development-path discussions for therapeutic and diagnostic radiopharmaceuticals.
- Contributed to 3 peer-reviewed publications.
- Mentored one new graduate who has grown into a core team member leading a key radiopharmaceutical project.