Director, Clinical Operations

Tr1X • San Diego, CA

2d • Onsite

About The Position

The Director, Clinical Operations provides strategic leadership and operational oversight for the implementation and execution of clinical trials from study start-up through close-out. The Director is accountable for leading cross-functional clinical study teams; directing contract research organizations (CROs), study vendors, and investigative sites; and ensuring all clinical trial activities are executed in alignment with corporate objectives, timelines, budgets, regulatory requirements, GCP guidelines, and internal SOPs. This role serves as a key operational leader within the organization and is responsible for mentoring, developing, and supervising clinical operations personnel.

Requirements

• Bachelor’s degree in a scientific or healthcare-related discipline with a minimum of 10 years of progressive clinical operations experience, including at least 5 years of direct sponsor clinical study management and leadership experience.
• Demonstrated leadership experience managing complex global or multi-center clinical trials across multiple phases of development.
• 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 skills with 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 clinical trials, including operational strategy, study oversight, monitoring, and close-out activities.
• Advanced experience with clinical trial systems including eTMF, CTMS, EDC, safety databases, and other clinical technologies.
• Exceptional strategic thinking, problem-solving, organizational, communication, and executive presentation skills.
• Ability to independently manage competing priorities while leading within a matrixed cross-functional organizational structure.
• 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.

Nice To Haves

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

Responsibilities

• Provide strategic leadership as the Clinical Study Lead for cross-functional teams to ensure study start-up, enrollment, maintenance, and close-out activities are executed on schedule, within budget, and in accordance with quality expectations.
• Direct and oversee all aspects of clinical study management to ensure operational excellence, inspection readiness, and delivery of high-quality clinical data.
• Lead the clinical operational development, review, and finalization of clinical trial protocol synopses, protocols, protocol amendments, and other key study-related documents.
• Lead the CRO and vendor selection strategy for outsourced activities, including RFP development, bid management, proposal evaluation, budget negotiations, and executive-level vendor selection decisions.
• Direct negotiation, execution, and oversight of contracts and scopes of work with CROs, study vendors, consultants, and investigative sites.
• Oversee the development and maintenance of critical study documents, including informed consent templates, management plans, study trackers, and operational plans, ensuring appropriate delegation and accountability.
• Chair and lead internal and external clinical study meetings, governance reviews, and cross-functional operational discussions, ensuring alignment of objectives, decisions, and action items.
• Partner strategically with Regulatory Affairs to ensure timely preparation and submission of site essential regulatory documentation to the FDA and other regulatory authorities.
• Develop and oversee clinical monitoring strategies and monitoring plans to ensure compliance, quality oversight, and operational consistency across studies and vendors.
• Provide strategic oversight for case report form (CRF) design, edit check development, and data collection methodologies in partnership with Data Management and Clinical Development.
• Lead site initiation planning and execution activities, including oversight of training materials, presentations, and investigator engagement strategies.
• Provide leadership and governance oversight of CROs, field monitors, and clinical vendors to ensure contractual obligations, quality metrics, and operational deliverables are achieved.
• Establish oversight processes for monitoring visit reports, protocol deviations, CAPAs, and action item resolution to ensure quality and compliance standards are maintained.
• Direct and oversee study-wide operational activities including vendor management, biospecimen handling, investigational product logistics, investigator payments, data quality oversight, and centralized records management.
• Lead the review and analysis of clinical data reports to identify operational, safety, and efficacy trends and communicate findings to cross-functional leadership and governance committees.
• Ensure Trial Master File (TMF) oversight and inspection readiness throughout the duration of all assigned studies.
• Lead and facilitate internal clinical program meetings, investigator meetings, safety review committees, and other cross-functional governance forums.
• Partner with departmental leadership to define and execute clinical development operational strategies, resource planning, and process optimization initiatives.
• Proactively identify operational risks and implement mitigation strategies to ensure study continuity, compliance, and successful execution.
• Travel to clinical sites, investigator meetings, and vendor locations as required, up to 15%.
• Foster a culture of accountability, collaboration, operational excellence, and continuous improvement within a fast-paced, dynamic clinical development environment.
• Perform additional strategic and operational responsibilities as required to support evolving business and clinical development objectives.

Benefits

• discretionary annual target bonus
• incentive stock options
• 401(k) retirement plan with company contribution
• health and welfare insurance plans for employees (and their families) that include medical, dental, vision, long-term and short-term disability, and life insurance
• paid time off (PTO)
• paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Director