Vice President, Clinical Development, Oncology

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.

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.

• 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.

• 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.

• 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…