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Director Clinical Operations (San Diego)

Director Clinical Operations (San Diego)

EPM ScientificSan Diego, CA, United States
11 days ago
Job type
  • Temporary
Job description

Director, Clinical Operations

San Diego, CA - Onsite

$180,000-$2100,000

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
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    Clinical San Diego • San Diego, CA, United States

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