Study Director
Core
Lead and supervise the technical conduct of regulatory biocompatibility studies, ensuring compliance with GLP regulations and managing laboratory operations.
Role type
Senior Study Director (Biocompatibility/Regulatory Testing)
Builds
Regulatory-compliant test reports and study documentation for sponsors
Domain
Life sciences / Biocompatibility testing / Regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GLP compliance, study protocol design, data interpretation, report writing, laboratory management, regulatory liaison, experimental design, SOP development, team supervision
Preferred skills
EPA/FDA/DOT/OECD/ISO regulatory familiarity, hands-on test execution knowledge, administrative leadership
Technologies
GLP standards, ISO standards, EPA regulations, FDA regulations, DOT regulations, OECD guidelines
Responsibilities
Supervise study conduct and technical staff; develop and implement study protocols; interpret and report study results; ensure GLP compliance; liaise with sponsors and regulatory agencies; manage study schedules and financial tracking; train scientists on procedures.
Seniority
Senior, hands-on IC with management duties