Director, Clinical Operations

Tr1X•San Diego, CA

3d•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.
Experience in cell and/or gene therapy clinical trials preferred, particularly within Multiple Sclerosis, Inflammatory Bowel Disease, or other autoimmune indications.
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.
Travel is required up to 15%.

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.