Clinical Safety Officer

You will own the operational and strategic oversight of safety monitoring for human use research, and lead the qualitative research activities to train, evaluate, and improve the safety and efficacy of the next generation of digital mental health tools. Collaborate with data and engineering teams, using your clinical expertise to improve automated identification and response to clinical risk events in text data from digital tools. Develop and maintain the comprehensive safety monitoring plan across research studies developing the next generation of digital mental health tooling. Oversee adverse event (AE) and serious adverse event (SAE) management, ensuring collection, evaluation, and reporting per ICH-GCP and local regulations. Interface with IRB, DSMB, and other safety monitoring boards. Train study teams on safety processes, reporting timelines, and GCP requirements; serve as the escalation point for safety issues. Conduct qualitative interviews with participants to capture real-world clinical safety and efficacy insights and refine monitoring protocols.