Senior Director, Clinical Operations

South San Francisco, California, United States·Posted today

aimlbiotechgcp

<div class="content-intro">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.</div>Position summary 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. 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 Executive 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 Executive 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 <ul> <li>Serve as head of clinical operations, accountable for the operational strategy, delivery, and performance of Xaira’s clinical portfolio.</li> <li>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.</li> <li>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.</li> <li>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.</li> <li>Develop and manage the clinical operations budget and long-range resource plan in alignment with program milestones and corporate objectives.</li> </ul> Study delivery and portfolio oversight <ul> <li>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.</li> <li>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.</li> <li>Ensure site identification, activation, and performance management practices are capable of finding and enrolling biomarker-defined and other narrowly defined patient populations.</li> <li>Review protocols for operational feasibility, identify execution risk early, and bring practical alternatives to the study team before timelines, cost, or quality are affected.</li> <li>Lead risk-based quality management, including identification of critical-to-quality factors, risk assessment, monitoring strategy, and escalation.</li> <li>Provide clinical operations content and documentation for IND and CTA submissions, health authority requests, and regulatory inspections.</li> </ul> Outsourcing, vendor, and site partnership <ul> <li>Define and execute the outsourcing strategy across CROs, central and specialty laboratories, biomarker and imaging partners, IRT, eCOA, and other specialist providers.</li> <li>Lead vendor selection, contracting, and governance, establishing performance measures, escalation paths, and issue and CAPA resolution, and address underperformance early and directly.</li> <li>Own study budgets, contracts, change orders, accruals, and invoice reconciliation, maintaining discipline around scope and value.</li> <li>Build trusted relationships with investigators and site staff, and reduce the operational burden that limits site performance.</li> </ul> Quality, compliance, and inspection readiness <ul> <li>Ensure clinical studies are conducted in accordance with ICH GCP, applicable global regulations, and company procedures.</li> <li>Partner with Quality Assurance to design, develop, and implement the clinical operations SOP framework, study document templates, change controls, and training programs, scaled appropriately for a company conducting its first trials.</li> <li>Establish and maintain trial master file quality, data integrity, and documentation standards from the outset.</li> <li>Lead clinical operations inspection readiness, including preparation for BIMO and other health authority inspections, mock inspections, and remediation.</li> </ul> Data, technology, and AI-enabled execution <ul> <li>Partner with Translational Science, BioMedical AI, data science, biostatistics, and engineering to translate biomarker and patient-selection strategies into executable study plans.</li> <li>Define how clinical and biomarker data are captured, transferred, and reviewed so that teams can make timely decisions and the data remain usable in downstream analyses and models.</li> <li>Select and implement the clinical systems landscape, including EDC, CTMS, eTMF, IRT, and eCOA, with emphasis on fit for a small organization and clean data flow.</li> <li>Apply analytics, automation, and AI-enabled tools where they measurably improve feasibility, site selection, enrollment forecasting, monitoring, and risk identification, and evaluate approaches such as model-informed design and digital endpoints on their practical value to each study.</li> </ul> Cross-functional partnership and communication <ul> <li>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 and on schedule.</li> <li>Represent clinical operations on program teams, in governance forums, and in interactions with collaborators and partners, and contribute to development planning and portfolio decisions.</li> <li>Give leadership a clear and current view of study status, spend, risk, and the decisions required.</li> </ul> Qualifications <ul> <li>Bachelor’s degree in a scientific or health-related discipline required. An advanced degree is preferred but not required.</li> <li>A minimum of 15 years of clinical operations experience in biotechnology, pharmaceuticals, or a CRO, including end-to-end study leadership.</li> <li>At least 7 years of direct line management experience, including hiring, development, and performance management of clinical operations staff.</li> <li>Demonstrated experience leading early phase studies, including first-in-human, with accountability for at least one study from start-up through database lock.</li> <li>Oncology clinical operations experience, including start-up and enrollment of studies in biomarker-defined or otherwise narrowly defined patient populations.</li> <li>A proven record of CRO and specialist vendor management, including selection, governance, budget and change order control, and direct resolution of underperformance.</li> <li>Strong working knowledge of ICH GCP and applicable global regulations, with the judgment to apply them proportionately in a small-company environment.</li> <li>Experience establishing or substantially rebuilding clinical operations infrastructure, including SOPs, systems, and inspection readiness.</li> <li>Excellent influencing, negotiation, problem-solving, and communication skills, with experience presenting to executive leadership.</li> <li>Ability to operate at both strategic and hands-on levels in a small, fast-moving organization.</li> </ul> Preferred qualifications <ul> <li>Experience at a company conducting its first clinical trials or standing up a clinical operations function.</li> <li>Experience with protein or antibody therapeutics, and with precision medicine or biomarker-enriched studies.</li> <li>Global study experience, including multi-region start-up and country strategy.</li> <li>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.</li> <li>Experience implementing or migrating clinical systems such as EDC, CTMS, eTMF, IRT, or eCOA.</li> <li>Direct experience supporting a BIMO or other health authority inspection.</li> </ul> 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.

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