EXPLORE YOUR ROLE AS A STUDY DIRECTOR
We’re seeking candidates that have prior experience as a study director in a GLP environment with a PhD degree in a related field. In this role, you will:
- Take responsibility for the technical conduct of a study in addition to the interpretation, analysis, documentation and reporting of results.
- Develop protocols and ensure that the protocol, including any changes, is approved and is in compliance with appropriate SOPs, GLPs, and regulatory agency guidelines.
- Monitor progress and status of assigned studies.
- Ensure that all experimental data, including observations of unanticipated responses to the test system, are accurately recorded and verified.
- Direct preparation of reports, interpret results and ensure compliance with the protocol and regulatory requirements, and submit results to the client.
- Participate in study-specific client visits.
APPLY YOUR SKILLS AND EXPERTISE
In the Study Director role, we’re looking for:
- Knowledge of cell and gene therapy, ocular, general toxicology AND/OR biologics study design and conduct in adherence to regulatory guidance
- Knowledge in planning, negotiation and process innovation
- Demonstrated ability to interact effectively with all staff and management levels
- Demonstrated problem solving and decision-making skills
- Advanced knowledge of GLPs and regulatory agency guidelines
- Strong English writing and communication skills
- Advanced knowledge of computers and programs (e.g., word processing and spreadsheet applications)
WHAT WE CAN OFFER YOU
We offer a comprehensive benefits package. On the job, we offer development opportunities to make the most of your extraordinary potential and build your flexible and rewarding career.
- PhD in toxicology or related subject, DVM or equivalent degree. Experience may be substituted for education.
- Three to five years of related experience. Relevant experience may be substituted for years of related experience.
- Skilled in performing scientific presentations and preparing scientific publications.
Job Number 2019-29045