Director Clinical Development

Associate Director / Director / Senior Director, Clinical OperationsPosition SummaryThe 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 ResponsibilitiesLead operational planning and execution of clinical trials from study start-up through close-outManage CROs and external vendors, including oversight of timelines, deliverables, quality, and budgetsDevelop and maintain clinical trial operational plans and risk mitigation strategiesEnsure enrollment, data collection, and trial milestones are achieved according to timelinesIdentify and proactively manage study risks, issues, and mitigation strategiesCollaborate with cross-functional stakeholders including Clinical Development, Regulatory, Data Management, Biostatistics, and Medical AffairsServe as primary operational contact for investigational sites and external partnersParticipate in vendor selection, including RFP development, bid review, and contract oversightOversee clinical trial documentation including monitoring plans, study plans, and operational deliverablesSupport development of clinical protocols, statistical analysis plans, and clinical study reportsEnsure compliance with GCP, regulatory requirements, and internal SOPsParticipate in site selection and oversee site performance and engagementReview monitoring reports and audit findings to ensure quality and complianceOversee Trial Master File (TMF) quality and completenessSupport Data Monitoring Committee (DMC) activities when applicableParticipate in Site Initiation Visits and co-monitoring visits as neededLead cross-functional clinical trial team meetings and operational reviewsManage multiple clinical trials and priorities in a dynamic environmentQualificationsEducation & ExperienceBachelor’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 trialsLocal to San Diego to operate fully onsiteKnowledge & SkillsStrong knowledge of FDA, ICH, GCP, and global regulatory requirementsDeep understanding of clinical development lifecycle and trial executionExperience with CRO oversight and vendor managementExperience managing clinical trial budgets and timelinesStrong cross-functional leadership and collaboration skillsExperience supporting study start-up, enrollment, and close-out activitiesKnowledge of site management, monitoring, and data flow processesExperience with TMF oversight and audit readinessAbility to identify and manage operational risksAdditional SkillsExcellent organizational and project management abilitiesStrong written and verbal communication skillsAbility to lead cross-functional teamsExperience working in fast-paced, evolving environmentsProficiency in Microsoft Office and clinical trial management systemsExperience developing and reviewing clinical trial documentationTravelAbility and willingness to travel approximately 10–15% as needed