Senior Director, Clinical Operations

The posting, as Xaira wrote it

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 accountabili

[…]
rategic 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.

Location and travel

This position is based onsite at Xaira’s South San Francisco headquarters. Travel of approximately 20% is expected for investigator and site engagement, vendor governance, and scientific meetings.

Compensation

We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants. We offer a competitive package that includes base salary, bonus, and equity. The base pay range for this position is expected to be $250,000 - $311,000 annually; however, the base pay offered will vary depending on the market, job-related knowledge, skills and capabilities, and experience.

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.

TO ALL RECRUITMENT AGENCIES: Xaira Therapeutics does not accept agency resumes. Please do not forward resumes to our jobs alias or employees. Xaira Therapeutics is not responsible for any fees related to unsolicited resumes.