Director, Clinical Operations — Lead Global Trials & Teams

Aerogen Pharma

Raleigh (NC)

On-site

USD 120,000 - 160,000

Full time

31 hours ago
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Job summary

Aerogen Pharma in Raleigh, NC seeks a Director of Clinical Operations to lead end-to-end clinical programs, ensuring timelines, budgets, and regulatory compliance. You will oversee study documents, vendor management, and cross-functional collaboration, driving efficiency, quality, and strategic execution in early- and late-phase trials.

The role reports to the VP of Clinical Operations and demands strong leadership, communication, and problem-solving skills to advance neonatal and critical-care

Qualifications

  • Bachelor’s or master’s degree in a scientific field.
  • At least 10 years in clinical operations with 3+ years in a Director role.
  • Experience managing domestic and international early- and late-phase trials via CRO/vendor.
  • Demonstrated leadership and team management experience.
  • Excellent organizational and strategic planning skills.
  • Excellent written and verbal communication skills.

Responsibilities

  • Oversee clinical programs, timelines, budgets, and regulatory standards.
  • Lead development of protocols, informed consent forms, study manuals, and study reports.
  • Identify outsourcing needs and manage vendor/external consultant relationships.
  • Develop and implement strategic plans to improve trial efficiency and quality.
  • Ensure trials are conducted per ethical, regulatory, and SOP requirements.
  • Coordinate with internal departments and manage clinical operations staff.
  • Present progress reports to senior management and stakeholders.
  • Promote a culture of quality within Clinical Operations.

Skills

Leadership
Project management
Vendor management
ICH/GCP compliance
Strategic planning
Communication

Education

Bachelor’s or Master’s degree in a scientific field

Tools

CTMS

Job description

Aerogen Pharma in Raleigh, NC seeks a Director of Clinical Operations to lead end-to-end clinical programs, ensuring timelines, budgets, and regulatory compliance. You will oversee study documents, vendor management, and cross-functional collaboration, driving efficiency, quality, and strategic execution in early- and late-phase trials.

The role reports to the VP of Clinical Operations and demands strong leadership, communication, and problem-solving skills to advance neonatal and critical-care

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