Senior Director, Clinical Operations

About Xaira Therapeutics

Xaira is an innovative biotech startup focused on leveraging AI to transform drug discovery and development. The company is leading the development of generative AI models to design protein and antibody therapeutics, enabling the creation of medicines against historically hard-to-drug molecular targets. It is also developing foundation models for biology and disease to enable better target elucidation and patient stratification. Collectively, these technologies aim to continually enable the identification of novel therapies and to improve success in drug development. Xaira is headquartered in the San Francisco Bay Area, Seattle, and London.

Position summary

Xaira Therapeutics is seeking a Senior Director, Clinical Operations to establish and lead the company’s clinical operations function as its first programs move from IND into the clinic. Reporting to the Vice President, Head of Early Development, this individual will be accountable for the operational strategy, delivery, quality, and cost of Xaira’s clinical portfolio.

This is a founding functional leadership role. The Senior Director will determine which capabilities Xaira builds internally and which are delivered through partners, establish the processes, systems, and governance required to support that model, and hire and develop the team. The role carries full accountability for study delivery from start-up through database lock while the function is being built, and requires a leader who is comfortable setting strategy and executing directly in the same week.

Clinical operations at Xaira works closely with the science, the AI and data organization, and senior leadership. The Senior Director will translate development plans, biomarker strategies, and patient selection approaches into studies that can be executed well, and will shape how Xaira applies clinical data, analytics, automation, and emerging AI tools to trial planning and delivery.

Key responsibilities

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