Dominick de Guardia
- Role
- Medical Sciences Director, Thoracic Oncology at Amgen
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
Experience
Medical Sciences Director, Thoracic Oncology
Mar 2025 — Present
Lead medical sciences director (clinical scientist) on a high-priority, late-stage clinical trial as part of the tarlatamab development program. Serving as central medical monitor for a pivotal global Phase 3 trial in small-cell lung cancer (SCLC) to ensure data integrity, patient safety, and scientific rigor across the study’s execution. Led key study-start up (SSU) activities including the drafting and implementation of study Medical Monitoring Oversight Plan (MMOP) and Data Quality Training initiatives for cross-functional research teams. Drove major protocol and database enhancements in the form of amendment drafting and updated eCRF completion guidelines to optimize trial outcomes and processes. Work cross-functionally with Biostatistics, Global Development Operations (GDO), Safety, and Regulatory Affairs teams, leveraging advanced clinical data platforms (RAVE EDC, Veeva Vault eTMF, and Spotfire) to drive efficient, high-quality oncology data cleaning and trial execution. Well versed in the ever-changing thoracic oncology treatment landscape by tracking emerging therapies, new clinical guideline updates, and oncology conference developments to inform future clinical development strategy.
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