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Mona Shah, MD, Pediatric Hematology & Oncology, South San Francisco, CA, Lucile Packard Children's Hospital Stanford

MonaShahMDMS, MBA(she/her)

Pediatric Hematology & Oncology • South San Francisco, CA

Pediatric Coagulation Disorder Hematology

Senior Medical Safety Director, Safety Strategy Lead, Pediatric Safety Lead

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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.

Education & Training

  • Rice University
    Rice UniversityMBA, Executive, 2016 - 2018
  • Baylor College of Medicine
    Baylor College of MedicineMS, Clinical Investigation, 2007 - 2011
  • Baylor College of Medicine
    Baylor College of MedicineFellowship, Pediatric Hematology/Oncology, 2004 - 2007
  • Case Western Reserve Univ/Univ Hosps Cleveland Med Ctr/Rainbow Babies and Childrens Hospital
    Case Western Reserve Univ/Univ Hosps Cleveland Med Ctr/Rainbow Babies and Childrens HospitalResidency, Pediatrics, 2001 - 2004
  • University of Maryland School of Medicine
    University of Maryland School of MedicineClass of 2001

Certifications & Licensure

  • CA State Medical License
    CA State Medical License 2022 - 2026
  • TX State Medical License
    TX State Medical License 2007 - 2022
  • OH State Medical License
    OH State Medical License 2001 - 2004
  • American Board of Pediatrics Pediatrics
  • American Board of Pediatrics Pediatric Hematology-Oncology

Awards, Honors, & Recognition

  • Super Doctor SuperDoctors.com

Clinical Trials

Publications & Presentations

PubMed

Professional Memberships

Hospital Affiliations

Industry Relationships

  • Lead Medical Director, Genentech, Inc (Member of the Roche Group)I am responsible for designing/managing global clinical studies & programs (Phase I-III) in non-malignant hematology/rare diseases (nephrology, rheumatology, etc). I have experience in innovative study designs (adaptive/multi-drug), FDA/EMA pediatric investigational plans, and health authorities.2020 - Present

Dr. Mona Shah, Dr. Mona Shah, MD, Dr. M Shah