Vice President, Clinical Development, Oncology

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 Vice President, Early Clinical Development to lead development of the company’s oncology portfolio as it advances from discovery into the clinic. Reporting to the Senior Vice President, Translational Science and Early Clinical Development, the Vice President will be accountable for clinical development strategy, IND-enabling clinical planning, first-in-human study design and execution, and the progression of priority programs through clinical proof of concept and into late-stage development. This is a founding clinical development role. The Vice President will establish the clinical development function at Xaira, including its people, operating model, governance, and external network, and will serve as a visible member of the R&D leadership team with influence over portfolio strategy. Xaira integrates AI, computational biology, and large-scale experimental data across the discovery and development continuum. The Vice President will be expected to apply advanced analytics and model-derived insight to development strategy, trial design, patient selection, and evidence generation, and to exercise disciplined judgment about where these methods add value and where conventional approaches remain the better answer. Key responsibilities Clinical development strategy Develop and own integrated clinical development plans for priority oncology programs, from development candidate selection through clinical proof of concept and into registrational development. Define target product profiles, indication and tumor type strategy, dose and schedule, endpoints, biomarker strategy to inform dose, proof of mechanism and accelerated development opportunities using patient selection approaches with insights from Xaira’s AI platform. Translate insight from disease biology, functional genomics, proteomics, computational protein design, and translational studies into clinical hypotheses that can be tested in patients. Establish pre-specified go/no-go criteria for each program and make timely, well-reasoned recommendations to advance, redirect, or discontinue. IND enablement and first-in-human execution Lead the clinical strategy and clinical content for IND and CTA submissions, including clinical development plans, first-in-human protocols, Investigator’s Brochure clinical sections, and briefing documents. Establish starting dose, escalation scheme, and dose-limiting toxicity criteria in partnership with pharmacology, clinical pharmacology, PK/PD modeling, and toxicology, including MABEL or exposure-based approaches where appropriate. Design Phase 1 studies that deliver both dose determination and mechanistic insight, incorporating contemporary escalation methodology such as BOIN, mTPI, or Bayesian model-based designs, backfill and expansion cohorts, and randomized dose optimization consistent with FDA Project Optimus expectations. Provide scientific and medical oversight throughout Phase 1 execution, including cohort review, interpretation of emerging PK, pharmacodynamic, biomarker and response data, safety review committee and DSMB interactions, and protocol amendments. Translational and biomarker-driven development Working closely with the Translational Medicine team, define the translational and biomarker strategy for each program, including target engagement and pharmacodynamic endpoints, confirmation of mechanism of action in patients, characterization of resistance, and determination of the pharmacologically active dose range. Partner with the Biomedical AI team and X-Patient AI Disease Modeling team to design data collection, analysis and interpretation aimed at generating hypotheses related to mechanism and disease segmentation to inform clinical development strategy through patient selection, tumor type selection and combinations. Using data from the Translational platforms, including X-patient, design and implement patient selection strategy, including biomarker-defined populations, enrichment versus all-comers designs, assay selection and qualification, threshold definition, and the prospective evidence required to support a cut-off and CDx Assay Development. Transition to late-stage development Define and execute the path from dose expansion to registrational intent, including indication selection, single-arm versus randomized design, comparator and control strategy, endpoint selection across ORR, duration of response, PFS and OS and the assumptions underlying surrogacy, statistical considerations, and accelerated approval strategy where applicable. Lead End-of-Phase 1 and End-of-Phase 2 interactions and expedited program designation strategy, and secure health authority alignment on registrational population, dose, and endpoints. Ensure continuity of clinical, statistical, regulatory, operational, and diagnostic strategy into late-stage execution so that critical assumptions are not revisited in Phase 3. Regulatory leadership and patient safety Serve as the lead clinical representative in interactions with FDA, EMA, and other health authorities, and oversee clinical content across regulatory submissions, briefing packages, and responses. Hold accountability for participant safety across clinical programs, including oversight of medical monitoring, evaluation of safety signals, and partnership with pharmacovigilance on risk management. Ensure studies are conducted in accordance with GCP, ICH guidance, and applicable global regulatory requirements. AI, data, and advanced analytics Partner with Xaira scientists across BioMedical AI, computational biology, data science, engineering, biostatistics, and translational research to bring model-derived insight into clinical decision-making. Apply molecular, single-cell, multi-omic, imaging, real-world, and clinical data to patient selection, biomarker strategy, dose selection, endpoint definition, and trial design. Identify and prioritize practical applications of AI in oncology development, which may include trial simulation, dose–exposure–response modeling, protocol optimization, enrollment forecasting, digital pathology, external and synthetic control methods, predictive efficacy, and clinical data review. Establish standards for data quality, validation, explainability, bias assessment, documentation, and human oversight wherever a model informs a clinical decision. Design clinical studies so that the data generated also strengthens Xaira models and informs subsequent discovery and development, with tissue collection, sampling design, and consent structured accordingly. Organizational leadership and external engagement Build, lead, and develop the clinical development team, and establish the operating model, governance, and decision forums the organization requires as the pipeline expands. Select and manage CROs, central and specialty laboratories, imaging and diagnostic vendors, and consultants, retaining scientific ownership and decision authority within Xaira. Develop and manage the clinical development budget and resource plan in alignment with program milestones and corporate objectives. Establish and maintain relationships with academic and community oncology investigators, cooperative groups, key opinion leaders, patient advocacy organizations, regulators, an

Ähnliche Stellen in South San Francisco, California, United States

• Senior Director, Clinical Operations — Xaira Therapeutics (South San Francisco, California, United States, United States)
• Principal Scientist, Protein Engineering Jobs at Xaira Therapeutics — South San Francisco, CA — Xaira Therapeutics (South San Francisco, California, United States, United States)
• Procurement Manager bei Xaira Therapeutics — Xaira Therapeutics (South San Francisco, California, United States, United States)
• Research Associate / Senior Research Associate at Xaira Therapeutics — South San Francisco, CA — Xaira Therapeutics (South San Francisco, California, United States, United States)
• Scientist II, High Throughput Biology - Xaira — Xaira Therapeutics (South San Francisco, California, United States, United States)
• Contracts Manager at Neuralink — South SF, CA — Neuralink (South San Francisco, California, United States, United States)
• Principal Scientist Biology Jobs at Xaira Therapeutics — Xaira Therapeutics (South San Francisco, California, United States, United States)
• Dimensional Quality Engineer at Neuralink — South San Francisco, CA — Neuralink (South San Francisco, California, United States, United States)