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.
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