Sr. Director, Clinical Operations

What you'll do

• Plan and execute early clinical studies, including study timelines, budgets, forecasts, risks, and operational documentation.
• Select and oversee CROs, vendors, and clinical sites; manage study start-up and execution across the U.S., Europe, Australia, and other regions.
• Establish fit-for-purpose clinical operations processes and ensure studies meet protocol, ICH-GCP, regulatory, quality, and inspection-readiness requirements.

What they ask for

• 10+ years of progressive clinical operations experience in biotechnology or pharmaceutical industry.
• Direct experience leading first-in-human or Phase 1 studies from operational planning through site activation and ongoing execution.
• Experience managing study budgets, vendor contracts, scopes of work, change orders, timelines, and forecasts.
• BS/MS/PhD in a scientific, healthcare, or related discipline; strong knowledge of ICH-GCP and FDA, EU, and other ex-U.S. clinical trial requirements.

Nice to have

• Advanced degree; experience in both biotechnology and pharmaceutical company environments.
• Early-phase study experience in Australia, China, antibody or biologic programs, or specialized biomarker and bioanalytical strategies.

Pay

$213,000 - $280,000 USD base salary

Tools

AI/ML, CROs, ICH-GCP, TMF, FDA, EU

AI focus

No AI-related job duties; the posting notes that applicant data may be reviewed using AI-assisted screening tools.