Teams at Veristat

Coordinates cybersecurity procedures, monitoring, reporting, incident and vulnerability follow-up, audits, documentation, and continuous improvement. Oversees managed security providers, evaluates their findings and recommendations, coordinates internal remediation, and presents risks and strategies to leadership, customers, and staff. Supports security investigations, control assessments, regulatory inspections, audit responses, and security technology or compliance projects within a regulated life sciences environment.

Leads clinical data management activities from study start-up through database lock for complex clinical research projects. Oversees data quality, documentation, project teams, and multiple studies; ensures compliance with SOPs, sponsor requirements, ICH GCP, and regulatory guidelines. Provides technical leadership, mentoring, training, consulting, resource coordination, and expertise in clinical trial databases and EDC systems.

Leads strategic and operational regulatory consulting for pharmaceutical and biotech clients from early development through NDA/BLA. Prepares IND, NDA/BLA, orphan drug designation, fast-track, and FDA advice-request documentation; advises clients and internal teams; serves as a client and Health Authority liaison; leads FDA interactions; and supports business development and marketing. Provides technical and supervisory leadership while applying knowledge of ICH GCP, clinical trials, regulatory requirements, and CRO-pharmaceutical relationships.