Study Director

NorthernBio; Muskegon (MI); On-site; USD 90,000 - 150,000; Full time

Job summary

NorthernBio in the United States seeks a Research Scientist/Study Director to lead non-clinical studies under GLP, ensuring study integrity and regulatory compliance. You will act as the single point of control for study planning, execution, data collection, and reporting.

The ideal candidate has 5–7 years in the CRO industry as a Toxicologist, with strong experience in study design, data analysis, and scientific writing. Excellent communication and attention to regulatory detail are essential.

Qualifications

• Master’s degree or equivalent in a related discipline; PhD preferred.
• 5 years GLP-compliant lab experience preferred.
• Experience with peer-reviewed publications and scientific writing.
• Proficiency with Microsoft Office and ability to learn new applications.
• Excellent written and oral communication skills.
• Knowledge of GLPs (FDA, OECD, and MHLW) and other federal regulations relating to the care of laboratory animals.

Responsibilities

• Serve as Study Director for non-clinical studies and control overall planning.
• Conduct data interpretation, analysis, documentation, and reporting of results.
• Generate protocol and ensure protocol changes are approved and followed.
• Ensure all raw data, documentation, and final reports are archived.
• Interface with Sponsors, Vendors, Contributing Scientists and Principal Investigators.
• Other duties as assigned.

Skills

GLP Compliance

Study Design

Data Analysis

Scientific Writing

Communication Skills

Education

Master’s Degree or equivalent in a related discipline

PhD preferred

Job description

The Research Scientist/Study Director will engage in serving as the single point of study control and is responsible for the overall planning and conduct of the non-clinical investigations in accordance with applicable regulatory guidelines and contemporary scientific practice. Additionally, the RS will ensure that all Good Laboratory Practices (GLP) are met and the outcome of the study is valid and reliable.

**We are specifically looking for an experienced Toxicologist in the CRO Industry, with 5-7 years of experience.

Role Responsibilities

• Represent the single point of control for all aspects of a study while serving as Study Director for non-clinical studies.
• Responsible for the technical conduct of the study as well as for the interpretation, analysis, documentation, and reporting of results.
• Generate protocol and ensure that the protocol, including any changes, are approved and followed.
• Ensure all experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified.
• Ensure that unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.
• Ensure that Test systems are as specified in the protocol.
• Ensure compliance with the protocol, amendments, and regulatory agencies as identified in the protocol and SOPs.
• Ensure that all raw data, documentation, protocols, specimens, and final reports are archived at the conclusion of a study.
• Interface with Sponsors, Vendors, Contributing Scientists and Principal Investigators.
• Other duties as assigned

Role Requirements

• Master’s Degree or equivalent in a related discipline required, PhD preferred.
• 5 years of experience in a GLP-compliant laboratory preferred.
• Experience with peer-reviewed publications, presentations, and scientific writing.
• Proficiency with Microsoft Office and the ability to learn and use additional applications.
• Excellent written and oral communication skills.
• Knowledge of GLPs (FDA, OECD, and MHLW) and other federal regulations relating to the care of laboratory animals.
• Ability to handle common laboratory species.
• Strong understanding of study design and protocols.
• Strong understanding of laboratory operations and data collection.
• Ability to work under specific time constraints.