Senior Director, Clinical Operations

The role

Establish and lead the clinical operations function as Xaira's first programs move from IND into the clinic. Own the operational strategy, delivery, quality and cost of the clinical portfolio, including study delivery from start-up through database lock.

What you will do

• Serve as head of clinical operations, accountable for strategy, delivery and performance of the clinical portfolio.
• Define the clinical operations operating model, deciding what is built internally and what goes to partners.
• Hire, lead and develop the clinical operations team and manage its performance.
• Hold accountability for operational delivery of all clinical studies from start-up through database lock.
• Define and execute the outsourcing strategy across CROs, laboratories and other specialist providers.
• Own study budgets, contracts, change orders and invoice reconciliation.
• Ensure studies follow ICH GCP and applicable regulations, and lead inspection readiness.
• Define how clinical and biomarker data are captured and reviewed, and select clinical systems.
• Apply analytics, automation and AI tools where they improve feasibility, site selection and monitoring.
• Give leadership a clear view of study status, spend, risk and required decisions.

Required qualifications

• Bachelor's degree in a scientific or health-related discipline.
• At least 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 and performance management.
• 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 in biomarker-defined or narrowly defined populations.
• Proven record of CRO and specialist vendor management, including selection, governance and budget control.
• Working knowledge of ICH GCP and applicable global regulations.
• Experience establishing or rebuilding clinical operations infrastructure, including SOPs, systems and inspection readiness.
• Excellent influencing, negotiation, problem-solving and communication skills, including presenting to executive leadership.
• Ability to operate at both strategic and hands-on levels in a small, fast-moving organization.

Nice to have

• 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 strategies and applying analytics, AI, digital endpoints or model-informed approaches.
• Experience implementing or migrating clinical systems such as EDC, CTMS, eTMF, IRT or eCOA.
• Direct experience supporting a BIMO or other health authority inspection.
• An advanced degree.

Benefits

• Competitive compensation and benefits package.
• Base salary, bonus and equity.
• Open, flexible and friendly work environment.
• Platform to develop long-term careers.
• Summary of Benefits available to all applicants.

Before you apply

• Xaira does not accept agency resumes; unsolicited agency resumes are not paid for.

About the company

Xaira Therapeutics is an AI-focused biotech startup using generative AI to design protein and antibody therapeutics and foundation models for biology and disease. It is headquartered in the San Francisco Bay Area, Seattle and London.