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Niloy N. Shah

Head Of Global Quality, Ex-china at HUTCHMED

Niloy N. Shah M.S. has a diverse work experience that includes roles in various companies and organizations. Niloy N. is currently working as the Director of Clinical Quality Operations at HUTCHMED, where they utilize their deep knowledge of GCP to ensure regulatory compliance and clinical risk management. Niloy N. also supports the non-clinical team on GLP & OECD Toxicology studies and pre-clinical animal modeling studies.

Prior to their current role, Niloy worked as a Principle Consultant & Managing Partner at Verdem Health, a healthcare firm dedicated to promoting novel biotherapeutics and medical devices. Niloy N. provided management consulting, marketing consulting, and operational strategies, among other services.

Niloy N. has also served as a member of the Board of Directors at The WeHeal Foundation, a non-profit organization advocating for patient strategy for various disease types.

Niloy's previous experience includes founding and serving as President of NextGen Healthcare Solutions, working as a Graduate Teaching Assistant at Rutgers | School of Graduate Studies, and serving as a Laboratory Instructor and Office Assistant at Baylor University.

Additionally, they worked as the Director of Business Development- Healthcare at Vaddo, Inc. and as a Research and Clinical Assistant in Cytogenetics at MD Anderson Cancer Center.

Niloy N. Shah M.S. completed their Bachelor's degree in Biology/Biological Sciences, General at Baylor University from 2012 to 2016. In 2014, they also studied Emergency Medical Technology/Technician (EMT Paramedic) at Wharton County Junior College. Continuing their education, Niloy then pursued a Master of Science (M.S.) in Biomedical Sciences at Rutgers | School of Graduate Studies from 2016 to 2017.

In addition to their academic degrees, Niloy has obtained various certifications throughout their career. These include certifications in Leadership Insights on Being Accountable and Transitioning to Senior Leadership from Skillsoft, obtained in April 2023, as well as Advarra eReg 1300: Reviewer (Internal or External Monitor) Curriculum from Advarra University, obtained in November 2022. Niloy N. also holds certifications in DOT-Dangerous Goods, Good Clinical Practice (GCP), IATA-Dangerous Goods, First Aid (with AED), CITI-IRB, HIPAA, OSHA, and EMT-Basic. The specific institutions and years of obtaining these certifications are as follows:

- DOT-Dangerous Goods from Transportation Development Group in January 2021

- Good Clinical Practice (GCP) from The National Institutes of Health in January 2021

- IATA-Dangerous Goods from Transportation Development Group in January 2021

- First Aid (with AED) from Wharton County Junior College in June 2019

- CITI-IRB from Rutgers New Jersey Medical School in August 2016

- HIPAA from Rutgers New Jersey Medical School in August 2016

- OSHA from Rutgers University in August 2016

- EMT-Basic from Wharton County Junior College in August 2014

This comprehensive education history and certification background highlight Niloy N. Shah M.S.'s commitment to academic and professional development in the fields of Biomedical Sciences and Emergency Medical Technology.

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Timeline

  • Head Of Global Quality, Ex-china

    April 1, 2024 - present

  • Senior Director, Clinical Quality Operations

    January 1, 2024

  • Director Of Clinical Quality Operations

    September, 2021