Director, Regulatory & Administrative Affairs - Institute for Transformative Clinical Trials

**Job Description**

The Director of Regulatory & Administrative Affairs for the Mount Sinai Institute for Transformative Clinical Trials provides strategic leadership and operational oversight for regulatory, safety, and administrative activities supporting a portfolio of sponsor-led, investigator-initiated, federally funded, and industry-sponsored clinical research studies.

Serving within an Academic CRO and Data and Clinical Coordinating Center environment, this position is responsible for regulatory oversight of domestic and international multicenter clinical trials conducted across participating research institutions. The Director provides leadership for regulatory affairs and safety operations activities across the study lifecycle, and ongoing support of participating sites within multicenter clinical research networks.

The ideal candidate will have demonstrated experience with FDA and Health Canada submissions, including Investigational New Drug (IND) a...