Remote Clinical Operations Director, Trials & Compliance

Biolojic; Northern (KY); Hybrid; USD 220,000 - 280,000; Full time

Benefits offered by this job

4 weeks PTO

Health, dental & vision

401k with match

Job summary

Biolojic Design seeks a Head of Clinical Operations to lead all clinical operations activities, overseeing trials across sites, vendors, and regulatory compliance. The role reports to the Chief Medical Officer and supports the execution of First-in-Human studies.

The candidate will manage budgets, timelines, and SOP development while driving process improvements in trial management within a startup environment. East Coast location with US travel required.

Qualifications

• Bachelor’s degree (or equivalent) in a relevant scientific field.
• 7+ years of clinical trial experience, including management and monitoring.
• ICH/GCP training.
• 5+ years in clinical program management.
• Experience with Phase 1-2 trials and First-in-Human studies preferred.
• Strong knowledge of drug development and regulatory guidelines.
• Excellent communication skills (oral and written).
• Able to travel monthly to US HQ and sites.

Responsibilities

• Lead and supervise all clinical operations activities in accordance with GCP and regulatory guidelines.
• Oversee site qualification, initiation, monitoring, and close-out activities.
• Develop SOPs and training materials for Clinical Operations.
• Manage budgets, timelines, and vendor relationships including CROs.
• Ensure Trial Master File readiness and inspection readiness.
• Provide updates on risks and issues and drive resolutions.

Skills

Excellent communication

Organizational skills

Time management

Team player

Travel readiness

Education

Bachelor’s degree in a scientific field

Tools

Medidata Rave

Microsoft Office

Job description

Biolojic Design seeks a Head of Clinical Operations to lead all clinical operations activities, overseeing trials across sites, vendors, and regulatory compliance. The role reports to the Chief Medical Officer and supports the execution of First-in-Human studies.

The candidate will manage budgets, timelines, and SOP development while driving process improvements in trial management within a startup environment. East Coast location with US travel required.