Director, Clinical Operations

Tr1X•San Diego, CA

3h•$210,000 - $230,000•Onsite

About The Position

The Director, Clinical Operations provides strategic leadership and operational oversight for clinical trials from study start-up through close-out. This role leads cross-functional clinical study teams and oversees CROs, vendors, and investigative sites to ensure trial activities align with company objectives, timelines, budgets, regulatory requirements, GCP guidelines, and internal SOPs. The Director is also responsible for mentoring, developing, and supervising clinical operations personnel. The role oversees clinical study management, operational planning, vendor and site relationships, monitoring strategies, data quality, regulatory documentation, and Trial Master File readiness. It partners with Regulatory Affairs, Data Management, Clinical Development, and departmental leadership to support clinical development strategies, resource planning, risk management, and process improvement. The position is based on-site in San Diego, California, and requires travel of up to 15%.

Requirements

Bachelor’s degree in a scientific or healthcare-related discipline.
At least 10 years of progressive clinical operations experience, including at least 5 years of direct sponsor clinical study management and leadership experience.
Demonstrated leadership managing complex global or multi-center clinical trials across multiple development phases.
Extensive working knowledge of ICH/GCP guidelines, FDA regulations, and global clinical trial regulatory requirements.
Proven ability to lead cross-functional teams, influence stakeholders, and drive strategic clinical operations initiatives in a fast-paced environment.
Strong operational leadership and demonstrated expertise in study start-up, trial execution, vendor oversight, risk management, and inspection readiness.
Experience supporting pre-NDA programs and Phase 1 first-in-human trials, including operational strategy, study oversight, monitoring, and close-out.
Advanced experience with clinical trial systems, including eTMF, CTMS, EDC, safety databases, and other clinical technologies.
Strong strategic thinking, problem-solving, organizational, communication, and executive presentation skills.
Ability to independently manage competing priorities within a matrixed cross-functional organization.
Demonstrated success mentoring and developing high-performing clinical operations teams.
High level of professionalism, integrity, accountability, and business acumen.
Legally authorized to work for any employer in the U.S.
Willingness to travel up to 15%.

Nice To Haves

Experience in cell and/or gene therapy clinical trials, particularly in Multiple Sclerosis, Inflammatory Bowel Disease, or other autoimmune indications.

Responsibilities

Provide strategic leadership as Clinical Study Lead for cross-functional teams, ensuring study start-up, enrollment, maintenance, and close-out are completed on schedule, within budget, and to quality expectations.
Direct clinical study management to support operational excellence, inspection readiness, and high-quality clinical data.
Lead operational development, review, and finalization of clinical trial protocol synopses, protocols, amendments, and other study documents.
Lead CRO and vendor selection for outsourced activities, including RFP development, bid management, proposal evaluation, budget negotiations, and vendor selection decisions.
Negotiate, execute, and oversee contracts and scopes of work with CROs, vendors, consultants, and investigative sites.
Oversee development and maintenance of critical study documents, including informed consent templates, management plans, study trackers, and operational plans.
Chair and lead internal and external study meetings, governance reviews, and cross-functional operational discussions.
Partner with Regulatory Affairs on timely preparation and submission of essential site regulatory documentation to the FDA and other regulatory authorities.
Develop and oversee clinical monitoring strategies and plans for compliance, quality oversight, and operational consistency.
Provide strategic oversight for CRF design, edit check development, and data collection methods with Data Management and Clinical Development.
Lead site initiation planning and execution, including training materials, presentations, and investigator engagement strategies.
Oversee CROs, field monitors, and clinical vendors to ensure contractual obligations, quality metrics, and operational deliverables are met.
Establish oversight processes for monitoring visit reports, protocol deviations, CAPAs, and action item resolution.
Oversee study-wide operations, including vendor management, biospecimen handling, investigational product logistics, investigator payments, data quality, and centralized records management.
Lead review and analysis of clinical data reports to identify operational, safety, and efficacy trends and communicate findings to leadership and governance committees.
Ensure TMF oversight and inspection readiness throughout assigned studies.
Lead internal clinical program meetings, investigator meetings, safety review committees, and other governance forums.
Partner with departmental leadership on clinical development operational strategies, resource planning, and process optimization.
Identify operational risks and implement mitigation strategies to support study continuity, compliance, and successful execution.
Travel to clinical sites, investigator meetings, and vendor locations as required, up to 15%.
Foster accountability, collaboration, operational excellence, and continuous improvement in a fast-paced clinical development environment.
Perform additional strategic and operational responsibilities as needed to support business and clinical development objectives.
Mentor, develop, and supervise clinical operations personnel.