Director of Clinical Operations - Global Trials Leader

Aerogen Ltd; West Virginia; On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive bonus plan

Development opportunities

Diversity & inclusion initiatives

Job summary

Aerogen Pharma is seeking a Director of Clinical Operations to lead the management, oversight, and hands-on execution of global clinical programs. You will collaborate with functional leads to drive timelines, budgets, and regulatory compliance, reporting to the VP of Clinical Operations.

The role requires 10+ years in clinical operations, including 3+ years in a Director role, with strong CRO/vendor management and leadership capabilities.

Qualifications

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

Responsibilities

• Manage clinical operational functions and allocate/refer internal resources and CROs to meet timelines and budgets.
• Lead development of study documents (protocols, consent forms, manuals, brochures, study reports).
• Oversee outsourcing needs, vendor selection, and performance management.
• Develop strategic plans to improve efficiency, quality, and effectiveness of trials.
• Ensure trials comply with ethical standards, ICH/GCP, SOPs and regulatory requirements.
• Coordinate with internal departments to support trial execution.
• Lead clinical operations staff: recruitment, training, mentorship, performance evaluation.
• Maintain knowledge of regulatory developments and trial conduct.
• Prepare and present trial progress reports to senior management.

Skills

Clinical operations

Leadership

Vendor management

ICH GCP

Regulatory compliance

Strategic planning

Budget management

Education

Bachelor's or Master's in a scientific field

Tools

PM tools

Job description

Aerogen Pharma is seeking a Director of Clinical Operations to lead the management, oversight, and hands-on execution of global clinical programs. You will collaborate with functional leads to drive timelines, budgets, and regulatory compliance, reporting to the VP of Clinical Operations.

The role requires 10+ years in clinical operations, including 3+ years in a Director role, with strong CRO/vendor management and leadership capabilities.