Remote Study Director - GLP Toxicology Lead

Actalent; United States; Remote; USD 57,000 - 81,000; Full time

Job summary

Actalent is seeking a Study Director to supervise regulatory toxicology studies within a contract research organization. You will lead study design, execution, data interpretation, and reporting while ensuring GLP, EPA, FDA, DOT, OECD, ISO and other standards are met.

This role involves work with animal models to advance cancer research. You will supervise staff, coordinate studies, and serve as the primary liaison with sponsors in a fast-paced lab environment based in DAYTON, NJ.

Qualifications

• Hands-on toxicology and related assays experience in a regulated CRO/LA environment.
• Familiarity with EPA, FDA, DOT, OECD, GLP and ISO guidelines.
• Ability to supervise technical staff and coordinate multiple studies.

Responsibilities

• Supervise regulatory studies with day-to-day oversight of all phases.
• Design and implement study protocols ensuring regulatory compliance.
• Develop SOPs and experimental designs; supervise execution and data collection.
• Interpret and report study results to sponsors and stakeholders.
• Lead and mentor laboratory personnel; manage timelines and budgets.

Skills

Laboratory leadership

GLP regulatory knowledge

Scientific report writing

Communication with sponsors

Project coordination

Education

Bachelor of Science

Job description

Actalent is seeking a Study Director to supervise regulatory toxicology studies within a contract research organization. You will lead study design, execution, data interpretation, and reporting while ensuring GLP, EPA, FDA, DOT, OECD, ISO and other standards are met.

This role involves work with animal models to advance cancer research. You will supervise staff, coordinate studies, and serve as the primary liaison with sponsors in a fast-paced lab environment based in DAYTON, NJ.