Transformative Leadership Advisory Member |
Shila Ndeh
Active Term: 06/2024 - 06/2025
Areas of Expertise
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Science Policy AnalystI am a Science Policy Analyst with over 16 years of experience in the drug development space. I currently lead the Extramural Research Program in the Office of New Drugs at FDA and serve on the Research Governance Council Communications Working Group. My current role involves connecting medical officers to external subject matter experts who collaborate through research to bridge knowledge gaps in areas of unmet needs. I develop and present seminar series on different mechanisms for collaborative research with external institutions to increase scientists’ engagement and awareness of the impact of research outcomes generated.
I am also a member of the Women of Color in Science, Technology, Engineering, and Mathematics (WoCSTEM) employee resource group, which seeks to increase representation of women of color in STEM fields. Previously, I served as a Regulatory Affairs Manager at IBA Molecular, where I led the project to submit three radiopharmaceutical products to the FDA using the abbreviated new drug application pathway. I also worked as a contract Clinical Documentation Specialist at MedImmue, where I led a team of contractors through the review and audit of the Trial Master File in preparation for the European Medicine Agency audit. In 2023, I obtained a Patient Advocate Professor Certificate from the University of Maryland. This certificate program increased my awareness and skills to advocate for patient centered research practices within my community as well as diversity and inclusion in clinical research. In 2022, I obtained my Project Management Certification from Duke Corporate Education in Association with Duke University. I hold a MS in Bioscience Regulatory Affairs from Johns Hopkins University and a BS in Journalism and Mass Communication from University of Buea. |
