Senior Director, Clinical Operations
About this role
Translating novel generative AI models and biological foundation models from the bench into human clinical trials requires establishing a brand new clinical operations function. Xaira Therapeutics needs a foundational leader to build the internal capabilities, external partnerships, systems, and governance necessary to take programs from IND into the clinic. This hire will address the challenge of operationalizing early-phase studies in biomarker-defined and oncology patient populations while shaping the application of analytics, automation, and AI-enabled tools to trial planning and delivery.
Operating as the head of clinical operations, this individual will balance high-level strategic decisions with direct, hands-on execution. The role involves designing the operating model, managing budgets, and overseeing study delivery from start-up through database lock. Working closely with translational science, biomedical AI, data science, and senior leadership, the director will ensure that complex development plans and patient-selection strategies translate into feasible, high-quality clinical studies.
Candidates who thrive in this environment are comfortable setting long-range resourcing plans while directly tackling operational roadblocks in the same week. A strong background in early-phase oncology trials, vendor management, and infrastructure creation in smaller biotechnology settings will prepare a leader to succeed in shaping this portfolio.
What you will do
- Define the clinical operations operating model, determining internal capabilities versus partner-delivered functions while establishing necessary 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.
- Hold full accountability for the operational delivery of all clinical studies from start-up through database lock and clinical study report.
- Define and execute the outsourcing strategy across CROs, central laboratories, biomarker and imaging partners, IRT, and eCOA providers.
- Ensure clinical studies adhere to ICH GCP, global regulations, and company standard operating procedures in partnership with Quality Assurance.
- Partner with biomedical AI, data science, and translational science to translate biomarker and patient-selection strategies into executable study plans.
What you need
- A bachelor’s degree in a scientific or health-related discipline is required.
- A minimum of 15 years of clinical operations experience within biotechnology, pharmaceuticals, or a CRO, including end-to-end study leadership.
- At least 7 years of direct line management experience involving hiring, staff development, and performance management.
- 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, encompassing start-up and enrollment in biomarker-defined or narrowly defined patient populations.
- Proven record of CRO and specialist vendor management, including selection, governance, budget control, and direct resolution of underperformance.
- Strong working knowledge of ICH GCP and applicable global regulations applied proportionately in a small-company environment.
Nice to have
- An advanced degree
Skills and tech stack
Questions candidates ask
Where is this role located?
Xaira is headquartered in the San Francisco Bay Area, Seattle, and London. This specific position is located in South San Francisco, California.
What is the salary range for this position?
The salary for this role ranges from $250,000 to $311,000.
What clinical focus areas are involved in the studies?
The portfolio includes early-phase studies such as first-in-human trials. It also requires oncology clinical operations experience, including start-up and enrollment of studies in biomarker-defined or narrowly defined patient populations.
Who does this position report to?
This individual reports to the Vice President, Head of Early Development. The role also works closely with science, the AI and data organization, and senior leadership.
The application is on the official Xaira Therapeutics careers page.
Apply on company site