layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Senior Director, Clinical Operations at Xaira Therapeutics

Functional leadership and operating model
Serve as head of clinical operations, accountable for the operational strategy, delivery, and performance of Xaira’s clinical portfolio.
Define the clinical operations operating model, including which capabilities are built internally and which are provided through partners, and establish the processes, governance, systems, and resourcing required to support it.
Hire, lead, and develop the clinical operations team across trial management, study start-up, site management, and clinical supply coordination, and manage individual and collective performance.
Establish functional metrics and management reporting covering timelines, enrollment, spend, quality, and risk, and present plans and material updates to R&D leadership and governance forums.
Develop and manage the clinical operations budget and long-range resource plan in alignment with program milestones and corporate objectives.
Study delivery and portfolio oversight
Hold accountability for the operational delivery of all clinical studies from start-up through database lock and clinical study report, including timelines, budgets, enrollment, and data quality.
Translate clinical development plans into integrated operational strategies covering country and site selection, feasibility, recruitment and retention, monitoring approach, data flow, risk management, and contingency planning.
Ensure site identification, activation, and performance management practices are capable of finding and enrolling biomarker-defined and other narrowly defined patient populations.
Review protocols for operational feasibility, identify execution risk early, and bring practical alternatives to the study team before timelines, cost, or quality are affected.
Lead risk-based quality management, including identification of critical-to-quality factors, risk assessment, monitoring strategy, and escalation.
Provide clinical operations content and documentation for IND and CTA submissions, health authority requests, and regulatory inspections.
Outsourcing, vendor, and site partnership
Define and execute the outsourcing strategy across CROs, central and specialty laboratories, biomarker and imaging partners, IRT, eCOA, and other specialist providers.
Lead vendor selection, contracting, and governance, establishing performance measures, escalation paths, and issue and CAPA resolution, and address underperformance early and directly.
Own study budgets, contracts, change orders, accruals, and invoice reconciliation, maintaining discipline around scope and value.
Build trusted relationships with investigators and site staff, and reduce the operational burden that limits site performance.
Quality, compliance, and inspection readiness
Ensure clinical studies are conducted in accordance with ICH GCP, applicable global regulations, and company procedures.
Partner with Quality Assurance to design, develop, and implement the clinical operations SOP framework, study document templates, change controls, and training programs, scaled appropriately for a company conducting its first trials.
Establish and maintain trial master file quality, data integrity, and documentation standards from the outset.
Lead clinical operations inspection readiness, including preparation for BIMO and other health authority inspections, mock inspections, and remediation.
Data, technology, and AI-enabled execution
Partner with Translational Science, BioMedical AI, data science, biostatistics, and engineering to translate biomarker and patient-selection strategies into executable study plans.
Define how clinical and biomarker data are captured, transferred, and reviewed so that teams can make timely decisions and the data remain usable in downstream analyses and models.
Select and implement the clinical systems landscape, including EDC, CTMS, eTMF, IRT, and eCOA, with emphasis on fit for a small organization and clean data flow.
Apply analytics, automation, and AI-enabled tools where they measurably improve feasibility, site selection, enrollment forecasting, monitoring, and risk identification, and evaluate approaches such as model-informed design and digital endpoints on their practical value to each study.
Cross-functional partnership and communication
Partner with Clinical Development, Translational Science, Regulatory Affairs, Safety, Biostatistics and Data Management, CMC and clinical supply, Finance, and Legal to keep study workstreams aligned and on schedule.
Represent clinical operations on program teams, in governance forums, and in interactions with collaborators and partners, and contribute to development planning and portfolio decisions.
Give leadership a clear and current view of study status, spend, risk, and the decisions required.

Senior Director, Clinical Operations

Employer job description

About Xaira Therapeutics

Key responsibilities

Qualifications

Preferred qualifications

Compensation

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