MonaShahMDMS, MBA(she/her)

Summary

• As a Senior Medical Director, I am the Safety Strategy Leader (SSL) for the Giredestrant program, in the breast/gynecology, and genitourinary disease areas, as part of Late-Stage & Marketed Medicines Safety (LMMS).
  
  As a Lead Medical Director, I was responsible for designing and managing global clinical studies and programs (Phase I-III) in non-malignant hematology and other rare diseases (nephrology, rheumatology, etc.). I have experience in innovative study designs (adaptive/multi-drug), with FDA/EMA pediatric investigational plans, and health authority interactions.
  
  Prior to joining industry, I served as an Associate Professor and physician administrator for over a decade. As a physician administrator, I was responsible for clinical operations, quality, safety, and change management in a large academic center. In addition to managing >150 faculty, I worked on building and expanding a clinical operational program dedicated to patient safety in close collaboration with colleagues across multiple divisions at one of the leading US Children's hospitals.
  
  In addition, I am an experienced Clinical Investigator in non-malignant hematology, particularly in hemostasis and thrombosis, with a demonstrated track record as a Principal Investigator of Phase II/III drug clinical trials through FDA approval. I served over 5 years on the Institutional Data Review and Clinical Research Oversight Committees.