Vice President, Clinical Development, Oncology

The role

Lead clinical development strategy for Xaira's oncology programs, from candidate selection through clinical proof of concept into late-stage development. Build and lead the clinical development function, including its people, operating model and governance, and work with AI and computational biology teams to apply model-derived insight to trial design and patient selection.

What you will do

• Develop and own integrated clinical development plans for priority oncology programs.
• Lead clinical strategy and clinical content for IND and CTA submissions.
• Design Phase 1 studies for dose determination and mechanistic insight.
• Define translational and biomarker strategy, including patient selection.
• Plan the path from dose expansion to registrational intent and lead End-of-Phase interactions.
• Serve as lead clinical representative with FDA, EMA and other health authorities.
• Hold accountability for participant safety across clinical programs.
• Build, lead and develop the clinical development team.
• Select and manage CROs, laboratories, vendors and consultants.
• Develop and manage the clinical development budget and resource plan.

Required qualifications

• MD or MD/PhD required.
• At least 12 years of clinical development experience in biotechnology or pharmaceutical industry.
• At least 5 years in a leadership capacity with accountability for programs and direct reports.
• Oncology experience across more than one tumor type, including dose-finding studies in patients with advanced cancer.
• Has led clinical strategy and authored clinical content for at least one oncology IND or CTA.
• Has advanced at least one oncology program from Phase 1 into late-stage or registrational development.
• Demonstrated biomarker-driven development experience.
• Direct experience applying AI, machine learning or advanced analytics to a clinical development or translational question.
• Extensive regulatory experience, including direct interaction with FDA and preferably EMA.
• Excellent written and verbal communication skills, including presenting to executive leadership and Boards of Directors.

Nice to have

• Completion of residency and fellowship in medical oncology or hematology/oncology, with board certification (strongly preferred).
• Contribution to an approved oncology therapeutic (strongly preferred).
• Experience with novel modalities such as engineered antibodies, bispecifics, antibody-drug conjugates, protein degraders, or cell and gene therapy.
• Companion diagnostic co-development experience.
• Experimental medicine, adaptive and model-informed drug development.
• Digital pathology or digital endpoints, causal inference, external control methodology, and real-world oncology data.
• Regulatory experience with novel analytics or AI-derived biomarkers.
• Prior clinical leadership within an AI-native or computational drug discovery company.
• Experience establishing an early clinical development function within a growing organization.

Benefits

• Competitive compensation and benefits package.
• Base salary, bonus and equity.
• Open, flexible and friendly work environment.
• Platform to develop long-term careers.
• Summary of Benefits available to all applicants.

Before you apply

• Recruitment agency resumes are not accepted.

About the company

Xaira Therapeutics is an AI-focused biotech startup developing generative AI models to design protein and antibody therapeutics and foundation models for biology and disease. It is headquartered in the San Francisco Bay Area, Seattle and London.