Director Clinical Operations

Director, Clinical Operations

San Diego, CA - Onsite

$160,000-$190,000

An emerging biotech company in San Diego is seeking a Director of Clinical Operations to lead early-stage clinical programs in the cardiology space. The company is advancing a novel therapeutic platform focused on gene regulation, with applications in complex diseases such as fibrosis and oncology.

This role will be responsible for overseeing clinical trial execution from start-up through completion, including vendor and CRO management, cross-functional coordination, and operational strategy. The ideal candidate will bring strong leadership in trial design, site engagement, and regulatory compliance, along with a hands-on approach to building clinical infrastructure in a fast-paced, science-driven environment.

Key Responsibilities:

• Lead execution of Phase 1 and 2 trials, including investigator-initiated studies
• Collaborate on protocol development and trial design
• Manage CROs, vendors, and external partners
• Coordinate across clinical science, regulatory, biostats, and other functions
• Oversee drug supply logistics and biospecimen management
• Develop and implement enrollment strategies and patient-facing materials
• Ensure GCP/ICH compliance and clinical quality systems
• Support safety monitoring and pharmacovigilance activities
• Manage study budgets, site payments, and financial tracking
• Serve as primary liaison for clinical sites and oversee site performance
• Contribute to data integrity, interim analyses, and reporting

Qualifications:

• Bachelor's or Master's in life sciences or related field
• 8+ years in clinical operations with experience leading trials end-to-end
• Strong understanding of global clinical development and regulatory standards
• Proven experience managing CROs and clinical vendors
• Skilled in budgeting, forecasting, and site payment systems
• Excellent communication and problem-solving skills
• Experience in RNA-based therapies, cardiology, or rare disease is a plus
• Willingness to travel as needed for site oversight

If you are interested in hearing more, please dont hesitate to apply.