Study Director – In Vivo Surgical (Large Animal Models)

Position Summary

We are seeking a hands-on Study Director with strong surgical experience in large animal models to lead and execute in vivo preclinical studies from initiation through final reporting. This role is ideal for a Study Director who is not only experienced in study management, but also actively involved in surgical procedures and technical execution.

Key Responsibilities

• Study Leadership & Execution
  Serve as the Study Director with full responsibility for study design, execution, and reporting
  Take ownership of studies upon contract award and ensure high-quality, on-time delivery
  Develop and refine protocols involving surgical models and large animal procedures
  Ensure technical conduct of studies aligns with protocols, including surgical and perioperative components

• Surgical & Technical Responsibilities (Core Focus)
  Perform and/or oversee surgical procedures in large animal models (e.g., swine, canine, ovine)
  Participate directly in pre-operative preparation, anesthesia coordination, intraoperative support, and post-operative care
  Provide technical guidance on model development, surgical techniques, and procedural optimization
  Ensure proper documentation of surgical procedures and outcomes
  Troubleshoot intraoperative or model-related challenges

• Team Coordination
  Lead study kick-off meetings and align surgical and in vivo teams
  Cookordinate with veterinarians, technicians, and research staff
  Delegate responsibilities while maintaining oversight of surgical and study execution
  Mentor staff on surgical techniques and best practices (as applicable)

• Client Communication
  Serve as the primary point of contact for clients
  Communicate study progress, surgical outcomes, and key milestones
  Provide technical insight on surgical models and study design
  Escalate risks or critical issues to leadership

• Data Review & Reporting
  Review surgical and study data for accuracy and completeness
  Support data analysis and interpretation
  Prepare and finalize comprehensive GLP study reports

• Compliance & Quality
  Ensure compliance with GLP (21 CFR Part 58), IACUC, and internal SOPs
  Document deviations, surgical complications, and corrective actions
  Maintain audit-ready documentation
  Support QA audits and regulatory inspections

• Study Oversight
  Manage multiple concurrent studies
  Cookordinate internal teams, veterinary staff, and external partners
  Oversee vendors or specialized surgical support as needed

Qualifications

• Required:

  • Bachelor’s or Master’s degree in Biology, Veterinary Science, or related field (DVM or PhD is a plus)
  • 6–9 Years Of In Vivo Research Experience, Including Significant hands-on experience with large animal models
  • Direct involvement in surgical procedures
  • 1–3 years in a Study Director or study lead role
  • Strong understanding of GLP regulations (21 CFR Part 58)
  • Proven ability to manage studies while contributing technically
  • Experience with anesthesia coordination, surgical workflows, or perioperative care
  • Strong organizational and communication skills

• PREFERRED:

  • Experience with swine, canine, or ovine surgical models
  • Background in device, cardiovascular, orthopedic, or translational surgical studies
  • DVM or surgical training highly desirable
  • CRO Experience
  • Client-facing Responsibilities
  • Experience mentoring or training technical staff