Study Director - Biocompatibility Studies
Core
Supervise and conduct regulatory biocompatibility studies, ensuring compliance with GLP regulations and managing laboratory operations.
Role type
Senior Study Director (Biocompatibility)
Builds
Regulatory-compliant biocompatibility test reports and data for sponsors
Domain
Life sciences / Biocompatibility testing / GLP compliance
Required skills
GLP regulation compliance, study protocol design, data interpretation, report writing, laboratory staff supervision, experimental design, regulatory liaison, SOP development
Preferred skills
Respirator usage, administrative leadership
Technologies
GLP, ISO standards, EPA, FDA, DOT, OECD regulations
Responsibilities
Supervise study conduct and technical staff; develop and implement study protocols; interpret data and write reports; liaise with sponsors and regulatory agencies; ensure GLP compliance; track study schedules and finances; train scientists in procedures.
Seniority
Senior, hands-on IC with management responsibilities