Study Director II

Our facility is entering an exciting phase of growth, adding innovative programs and resources to support cutting-edge biomedical research. As part of a national network of research sites, you'll have access to a broad community of experts, opportunities for cross-site collaboration, and continuous professional growth.

Key Responsibilities

Study Planning & Execution:
• Oversee all phases of assigned studies, including protocol development, resource planning (animals and personnel), and scheduling to ensure alignment with SOPs and sponsor expectations.

Sponsor Communication:
• Serve as the primary point of contact for study sponsors, maintaining regular, proactive communication throughout the project lifecycle.

Protocol & Compliance Oversight:
• Draft, review, and obtain approvals for study protocols. Ensure compliance with internal SOPs, USDA regulations, the Animal Welfare Act, IACUC requirements, and the Guide for the Care and Use of Laboratory Animals.

Data & Quality Management:
• Review and approve data collection forms, formulation instructions, and labels. Verify that all experimental data is recorded accurately and promptly address deviations or unexpected events.

Reporting & Documentation:
• Compile and submit study results in collaboration with senior staff and principal investigators. Ensure data and specimen archiving or transfer aligns with organizational standards and sponsor requirements.

Training & Supervision:
• Identify special methods and ensure technical staff receive appropriate training. Provide mentorship and guidance as needed.

Operational Support:
• Be available for extended hours, holidays, and weekends as required. Support facility-wide safety and PPE compliance efforts.

Qualifications
• Bachelor’s degree in a scientific discipline (e.g., Biology, Pharmacology, or related field).
• 3–5 years of experience in in-vivo study execution or direction, preferably in pharmacology, pharmacokinetics, or toxicology.
• Experience managing NHP studies is highly preferred.
• Strong communication and organizational skills with an emphasis on sponsor-facing roles.
• Familiarity with GLP/GCP environments is an asset, however, at this time the facility is not conducting GLP studies
• Comfortable using digital data systems and troubleshooting common issues.

Why Join Us?
• Innovative Environment: Be part of a growing research program focused on NHP studies.
• Collaborative Culture: Network with professionals across multiple U.S. research sites.
• Career Development: Access leadership support and training opportunities as the program scales.
• Meaningful Work: Contribute to impactful biomedical research that advances health and science.

Ready to take the next step in your research leadership career?

Let's talk and help shape the future of translational research.