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Salary: USD 250,000 - 311,000 / annual
Xaira Therapeutics is an innovative biotech startup leveraging AI to transform drug discovery and development, with a focus on generative AI models for protein and antibody therapeutics. The company is establishing its clinical operations function as its first programs move from IND into the clinic.
You will serve as the founding head of clinical operations, reporting to the Vice President of Early Development. This is a strategic leadership role with full accountability for the operational strategy, delivery, quality, and cost of Xaira's clinical portfolio. You will determine which capabilities are built internally versus delivered through partners, establish processes, systems, and governance, and hire and develop the clinical operations team. The role requires comfort setting strategy and executing directly in parallel.
Key responsibilities include:
**Functional Leadership**: Define the clinical operations operating model, hire and develop the team across trial management, study start-up, site management, and clinical supply coordination, establish functional metrics and reporting on timelines, enrollment, spend, quality and risk, and manage the clinical operations budget aligned with program milestones.
**Study Delivery & Portfolio Oversight**: Hold accountability for operational delivery of all clinical studies from start-up through database lock, translate development plans into integrated operational strategies covering site selection, feasibility, recruitment, monitoring, and risk management, ensure site practices support biomarker-defined patient populations, review protocols for feasibility and execution risk, lead risk-based quality management, and provide clinical operations content for regulatory submissions and inspections.
**Outsourcing & Vendor Management**: Define and execute outsourcing strategy across CROs, laboratories, biomarker partners, and other specialists, lead vendor selection and governance with performance measures and escalation paths, own study budgets and contracts, and build trusted relationships with investigators and site staff.
**Quality, Compliance & Inspection Readiness**: Ensure studies comply with ICH GCP and applicable regulations, partner with Quality Assurance on SOP frameworks and training, establish trial master file quality and documentation standards, and lead inspection readiness including preparation for BIMO and health authority inspections.
**Data, Technology & AI-Enabled Execution**: Partner with translational science and data teams to translate biomarker and patient-selection strategies into executable plans, define how clinical and biomarker data are captured and reviewed, select and implement clinical systems (EDC, CTMS, eTMF, IRT, eCOA), and apply analytics, automation, and AI tools to improve feasibility, enrollment forecasting, monitoring, and risk identification.
**Cross-Functional Partnership**: Work closely with Clinical Development, Regulatory Affairs, Safety, Biostatistics, CMC, Finance, and Legal to keep study workstreams aligned, represent clinical operations in governance forums and with collaborators, and provide leadership with clear visibility on study status, spend, and risk.
**Requirements**
- Bachelor's degree in a scientific or health-related discipline (required); advanced degree preferred
- Minimum 15 years of clinical operations experience in biotechnology, pharmaceuticals, or 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 narrowly defined patient populations
- 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 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
**Preferred Qualifications**
- 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
Approximately 20% travel expected for investigator and site engagement, vendor governance, and scientific meetings.
