EXPERIENCE Summary Write and review protocols that are in-line with the indication strategy. Conduct medical review and interpretation of efficacy and safety data from clinical trials. Responsible for the quality, coordination, medical accuracy, and timeliness of clinical study reports, review of Investigator Brochures, CTAs, Safety Data, Clinical Trial reports. Review and provide US feedback to protocols. Work with Clinical Team and other functions to prepare abstracts, manuscripts and presentations for external meetings. Review and approve abstracts publications & manuscripts for Investigator Initiated Trials to ensure clinical accuracy and appropriate safety review. Present and discuss data and findings at relevant internal and external meetings. Ensure adherence to GCP/ICH and Hospital Standard Operating Procedures (SOPs). Supports and participate in FDA meetings. Extensive interactions with academic thought leaders to optimize protocols and clinical trials for IIT programs. Coach and train internal colleagues as needed /requested

Highlights:

• Biopsy
• Data Management
• Management
• Research
• Chemotherapy
• Clinical Research
• Drafting
• Process Improvement
• Program Manager
• Radiation