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About the Role

Xaira Therapeutics is seeking an Executive Director, Clinical Operations to establish and lead the company’s clinical operations function as its first programs move from IND into the clinic. 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 where you will determine which capabilities Xaira builds internally and which are delivered through partners, establish the necessary processes, systems, and governance, and hire and develop the team. You will have full accountability for study delivery from start-up through database lock while the function is being built, requiring a leader comfortable setting strategy and executing directly within the same week. Clinical operations at Xaira works closely with the science, AI and data organization, and senior leadership. You will translate development plans, biomarker strategies, and patient selection approaches into executable studies and shape how Xaira applies clinical data, analytics, automation, and emerging AI tools to trial planning and delivery.

Responsibilities

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 internal vs. partner capabilities, and establish supporting processes, governance, systems, and resourcing.
Hire, lead, and develop the clinical operations team across trial management, study start-up, site management, and clinical supply coordination, and manage performance.
Establish functional metrics and management reporting covering timelines, enrollment, spend, quality, and risk, and present plans and updates to R&D leadership.
Develop and manage the clinical operations budget and long-range resource plan.
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 propose practical alternatives.
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.
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.
Own study budgets, contracts, change orders, accruals, and invoice reconciliation.
Build trusted relationships with investigators and site staff, and reduce the operational burden that limits site performance.
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.
Establish and maintain trial master file quality, data integrity, and documentation standards.
Lead clinical operations inspection readiness, including preparation for BIMO and other health authority inspections, mock inspections, and remediation.
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 for timely decision-making and downstream analysis.
Select and implement the clinical systems landscape, including EDC, CTMS, eTMF, IRT, and eCOA.
Apply analytics, automation, and AI-enabled tools to improve feasibility, site selection, enrollment forecasting, monitoring, and risk identification.
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.
Represent clinical operations on program teams, in governance forums, and in interactions with collaborators and partners.
Provide leadership with a clear view of study status, spend, risk, and required decisions.

Requirements

Bachelor’s degree in a scientific or health-related discipline required.
A minimum of 15 years of clinical operations experience in biotechnology, pharmaceuticals, or a CRO, including end-to-end study leadership.
At least 7 years of direct line management experience, including hiring, development, and performance management of clinical operations staff.
Demonstrated experience leading early phase studies, including first-in-human, with accountability for at least one study from start-up through database lock.
Oncology clinical operations experience, including start-up and enrollment of studies in biomarker-defined or otherwise narrowly defined patient populations.
A proven record of CRO and specialist vendor management, including selection, governance, budget and change order control, and direct resolution of underperformance.
Strong working knowledge of ICH GCP and applicable global regulations, with the judgment to apply them proportionately in a small-company environment.
Experience establishing or substantially rebuilding clinical operations infrastructure, including SOPs, systems, and inspection readiness.
Excellent influencing, negotiation, problem-solving, and communication skills, with experience presenting to executive leadership.
Ability to operate at both strategic and hands-on levels in a small, fast-moving organization.
Experience at a company conducting its first clinical trials or standing up a clinical operations function.
Experience with protein or antibody therapeutics, and with precision medicine or biomarker-enriched studies.
Global study experience, including multi-region start-up and country strategy.
Experience operationalizing biomarker or patient-stratification strategies, and applying analytics, automation, AI or machine learning tools, digital endpoints, or model-informed approaches in clinical development.
Experience implementing or migrating clinical systems such as EDC, CTMS, eTMF, IRT, or eCOA.
Direct experience supporting a BIMO or other health authority inspection.

Skills

AI
Drug Discovery
Drug Development
Generative AI Models
Protein Therapeutics
Antibody Therapeutics
Biomarker Strategies
Patient Stratification
Clinical Operations
Clinical Portfolio Management
Operational Strategy
Study Delivery
Quality Management
Cost Management
Process Establishment
System Implementation
Governance
Team Leadership
Talent Development
Performance Management
Metrics Development
Budget Management
Resource Planning
Study Start-up
Database Lock
Clinical Study Report
Country and Site Selection
Feasibility Analysis
Recruitment and Retention
Monitoring Strategy
Data Flow Management
Risk Management
Contingency Planning
Site Activation
Performance Management
Protocol Review
Risk Assessment
Escalation Procedures
IND Submissions
CTA Submissions
Health Authority Requests
Regulatory Inspections
Outsourcing Strategy
Vendor Management
Contract Negotiation
Change Order Control
Invoice Reconciliation
Investigator Relations
Site Staff Relations
ICH GCP Compliance
Global Regulations
SOP Development
Training Program Development
Trial Master File Management
Data Integrity
Documentation Standards
Inspection Readiness
BIMO Inspections
Translational Science
BioMedical AI
Data Science
Biostatistics
Engineering
Data Capture
Data Transfer
Data Review
Clinical Systems Implementation
EDC
CTMS
eTMF
IRT
eCOA
Analytics
Automation
AI-Enabled Tools
Enrollment Forecasting
Risk Identification
Model-Informed Design
Digital Endpoints
Cross-functional Collaboration
Clinical Development
Translational Science
Regulatory Affairs
Safety
Biostatistics and Data Management
CMC and Clinical Supply
Finance
Legal
Program Management
Governance Forums
Collaborator Interaction
Partner Interaction
Development Planning
Portfolio Decisions
Influencing
Negotiation
Problem-Solving
Communication
Executive Presentation
Strategic Thinking
Hands-on Execution

Location

South San Francisco headquarters

Work Type

Onsite
Full-time

Experience Level

Executive Director
15+ years clinical operations experience
7+ years direct line management experience
Experience leading early phase studies
Oncology clinical operations experience
Experience establishing or rebuilding clinical operations infrastructure
Experience at a company conducting its first clinical trials or standing up a clinical operations function
Global study experience

Education Level

Bachelor’s degree in a scientific or health-related discipline
Advanced degree preferred but not required

Salary/Compensations

$250,000 - $311,000 annually

Benefits

Competitive compensation and benefits package
Open, flexible, and friendly work environment
Platform for long-term career development
Base salary, bonus, and equity

About the Company

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.

Equal Opportunity

Xaira Therapeutics an equal-opportunity employer.
We believe that our strength is in our differences.
Our goal to build a diverse and inclusive team began on day one, and it will never end.