Associate Director / Director / Senior Director, Clinical Operations
Position Summary
The Associate Director/Director/Senior Director of Clinical Operations is responsible for the planning, execution, and oversight of clinical trials across multiple phases of development. This individual will ensure trials are conducted in accordance with protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and applicable regulatory requirements.
This role partners cross-functionally with internal teams and external vendors, including CROs, investigational sites, and service providers, to ensure high-quality, timely execution of clinical programs. The ideal candidate will bring strong operational leadership, vendor management experience, and the ability to manage complex clinical trials in a fast-paced environment.
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
