Senior Study Director-Principal Scientist- Toxicology
Company: Rpmresearch
Location: Columbia
Posted on: May 27, 2023
Job Description:
Featured Apply Location Columbia, MO
No Remote Type Direct Hire ID j-469 Preclinical/ Nonclinical Drug
Development We are a growing mid-size organization with multiple
sites looking for an accomplished Senior Study Director for our
Toxicology division to assist with the growth we are experiencing
and have plans to continue. Say Goodbye to the bureaucracy and the
administrative aspects of large cumbersome organizations and say
Hello to the Science! As a Senior Study Director, you will be
responsible for participating in the design of non-clinical /
preclinical in vivo studies as well as providing the scientific
oversight of the study. The study director will direct and
participate in the planning, organization, conduct and
interpretation of animal research according to the regulations,
protocols, standards and guidelines such as USDA, FDA, GLP, GCP,
etc. Be responsible for monitoring studies and providing updates to
both client sponsors and senior management. Ensure that the
employees are performing the study according to protocols and
Standard Operating Procedures (SOPs) These studies will involve
standard laboratory animal species (mice, rats, NHP, swine) across
typical test article types (Vaccines, Bio-pharmaceuticals, Small
Molecules). This role will encompass multiple site studies and
coordination thereof.
- Serve as Study Director and participate in research projects
including protocol development, preparation and administration of
test article, collecting and processing samples or tissues from
subjects.
- Plan an outline of research procedures to be followed during
the course of the experiment. Writing protocols and reports as well
as reviewing study schedules.
- Communicate with clients regularly regarding updates,
amendments, deviations, study results etc.
- Assist in ensuring that personnel allocated to performing
research activities for their studies have a clear understanding of
the research protocol, activities to be performed, and are properly
trained to conduct the procedures.
- Maintaining and completing multiple projects
simultaneously
- Developing Protocols
- Communicating with staff, management, and clients/sponsors
- Analysis, interpretation, and reporting of data from
non-clinical studies.
- Manage the conduct of study activities in compliance with the
protocol, amendments, and facility SOPs
- May also assist in the further development of SOPs, training
materials, and policies.
- Proactive recognition, documentation, and resolution of any
issues affecting the conduct of non-clinical studies.
- Maintain knowledge of FDA and other regulatory guidelines
- Work with the appropriate individuals to design and approve the
study protocols
- Perform other duties directed by the Director of Toxicology to
meet client needs.
- Develop and Maintan SOPs, assist in developing training
materials as needed, mentor junior Study Directors [Senior Study
Director and Principal Study Director]
- Provide Input on company policies, procedures, and
documentation necessary to maintain compliance with the GLP
guidelines and to ensure scientific rigor in the studies conducted
on site [Principal Study Director] Experience, Education, and
Specialized Knowledge and Skills: Study Director
- Education and Experience
- BS/BA in a relevant scientific field with 2 -4 years experience
- OR - Masters Degree in a relevant scientific field with 2 years
experience Senior Study Director
- Education and Experience
- BS/BA in a relevant scientific field with 6-8 years of related
drug development experience - OR - PhD in a relevant scientific
field with 4 years related experience
- Education and Experience
- BS/BA in a relevant scientific field with 16 years of related
drug development experience - OR - PhD in a relevant scientific
field with 12 years related experienceThis role will offer
relocation and will also offer partial Work From Home ability
(cannot work remote from another state) DABT or Board eligible
preferred Essential Skills include: leadership, good organizational
skills, knowledge of an experience with GLP (Good Laboratory
Practices), AAALAC and USDA guidelines, experience using computer
applications.
Keywords: Rpmresearch, Columbia , Senior Study Director-Principal Scientist- Toxicology, Executive , Columbia, South Carolina
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