Study Director - Biocompatibility Studies

Supervise and assist in the conduct of regulatory studies performed. Responsibilities include:
Supervise study conduct.
Assist in protocol development, design and implementation.
Responsibilities as stated in GLP regulations.
Data interpretation and report writing.
Client liaison.
Management Responsibilities:
Overall, day-to-day laboratory operation including supervision of technical staff assigned to your studies.
Scheduling and coordinating initiation and conduct of studies.
Ensure that the study schedule and financial aspects of each study that you are responsible for are accurately tracked on a regular basis.
Technical Responsibilities:
Overall responsibility for the technical conduct of all studies and interpretation, analysis, documentation and reporting of results. Specifically:
Establish test protocols and corresponding SOP's.
Develop experimental design and supervise implementation of experiments (tests).
Obtain sponsor approval of protocols and institute any necessary deviations from the test protocol with sponsor approval.
Ensure all experimental data is properly recorded and that observations of unanticipated responses of the test system are accurately recorded and verified.
Ensure tests are conducted in accordance with the test protocol and SOP.
Supervise conduct of all phases of the study, including participation in study conduct.
Ensure that GLP regulations are followed.
Interpretation, calculation, analysis, documentation and reporting of results.
Instruct, train and supervise scientists in all procedures.
Maintain liaison with sponsors, advising them of test results; and assisting with protocol development.
Maintain liaison with regulatory agencies in conjunction with: test protocols, and past or present studies submitted for regulatory approval, compliance with GLP's and appropriate test guidelines.
Ability to safely wear a respirator required
BS degree in a field related to their area of responsibility (e.g. animal science, chemistry, biology, microbiology).
Minimum of 5 years experience overseeing biocompatibility studies
Intimate working familiarity and/or ability to quickly learn and develop such familiarity with all government regulations dealing with testing particularly EPA, FDA, DOT, OECD, and GLP regulations in addition to ISO standards.
Hands-on working knowledge of the tests that will be under their responsibility.
Good administrative skills and leadership ability. Must communicate effectively and write well.

Employment type
Full-time

Work arrangement
No