Director Clinical Development

Key Responsibilities

• Lead operational planning and execution of clinical trials from study start-up through close-out
• Manage CROs and external vendors, including oversight of timelines, deliverables, quality, and budgets
• Develop and maintain clinical trial operational plans and risk mitigation strategies
• Ensure enrollment, data collection, and trial milestones are achieved according to timelines
• Identify and proactively manage study risks, issues, and mitigation strategies
• Collaborate with cross-functional stakeholders including Clinical Development, Regulatory, Data Management, Biostatistics, and Medical Affairs
• Serve as primary operational contact for investigational sites and external partners
• Participate in vendor selection, including RFP development, bid review, and contract oversight
• Oversee clinical trial documentation including monitoring plans, study plans, and operational deliverables
• Support development of clinical protocols, statistical analysis plans, and clinical study reports
• Ensure compliance with GCP, regulatory requirements, and internal SOPs
• Participate in site selection and oversee site performance and engagement
• Review monitoring reports and audit findings to ensure quality and compliance
• Oversee Trial Master File (TMF) quality and completeness
• Support Data Monitoring Committee (DMC) activities when applicable
• Participate in Site Initiation Visits and co-monitoring visits as needed
• Lead cross-functional clinical trial team meetings and operational reviews
• Manage multiple clinical trials and priorities in a dynamic environment

Qualifications

• Education & Experience: Bachelor’s degree required (advanced degree preferred); 8–15+ years of clinical operations experience within pharmaceutical or biotechnology industry (level dependent)
• Demonstrated experience managing Phase 1–3 clinical trials
• Local to San Diego to operate fully onsite
• Knowledge & Skills: Strong knowledge of FDA, ICH, GCP, and global regulatory requirements; deep understanding of clinical development lifecycle and trial execution; experience with CRO oversight and vendor management; experience managing clinical trial budgets and timelines; strong cross-functional leadership and collaboration skills; experience supporting study start-up, enrollment, and close-out activities; knowledge of site management, monitoring, and data flow processes; experience with TMF oversight and audit readiness; ability to identify and manage operational risks
• Additional Skills: Excellent organizational and project management abilities; strong written and verbal communication skills; ability to lead cross-functional teams; experience working in fast-paced, evolving environments; proficiency in Microsoft Office and clinical trial management systems; experience developing and reviewing clinical trial documentation
• Travel: Ability and willingness to travel approximately 10–15% as needed