Study Director - Biocompatibility Studies
Core
Lead and supervise regulatory biocompatibility studies, ensuring compliance with GLP regulations and delivering data interpretation and reports.
Role type
Senior Study Director (Biocompatibility)
Builds
Regulatory study reports and compliance documentation for sponsors
Domain
Life sciences / Biocompatibility testing
Required skills
GLP compliance, protocol development, experimental design, data analysis, report writing, regulatory liaison, laboratory management, SOP creation, test system observation, training scientists
Preferred skills
Familiarity with EPA, FDA, DOT, OECD, ISO standards, respirator usage
Technologies
GLP regulations, ISO standards, EPA guidelines, FDA guidelines, DOT guidelines, OECD guidelines
Responsibilities
Supervise study conduct and technical staff; develop and implement test protocols; interpret and report study results; liaise with sponsors and regulatory agencies; ensure GLP compliance; train scientists on procedures.
Seniority
Senior, hands-on IC with management responsibilities
