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Vice President, Clinical Development, Oncology

Xaira Therapeutics

Xaira Therapeutics seeks a Vice President to establish and lead clinical development for its oncology portfolio, advancing candidates from discovery through IND enablement and first-in-human trials. This founding role requires developing clinical strategy, designing early-phase studies, and integrating AI-derived insights into development planning and patient selection.

Responsibilities

  • Develop integrated clinical development strategies for priority oncology programs through proof of concept
  • Define target product profiles, indications, endpoints, and biomarker strategies leveraging company AI platform
  • Lead clinical content for IND and CTA submissions including protocols and Investigator's Brochure sections
  • Design Phase 1 studies incorporating contemporary escalation methods and mechanistic endpoints
  • Establish go/no-go criteria and provide scientific oversight throughout early trial execution

Requirements

  • Extensive experience in oncology clinical development and IND-enabling studies
  • Proven track record advancing first-in-human programs through Phase 1 trials
  • Expertise in dose escalation methodology and early clinical trial design
  • Strong understanding of translational research and biomarker-driven development strategies
  • Experience establishing clinical development functions and leading cross-functional teams
  • Familiarity with FDA regulatory pathways and Project Optimus guidance
Vacancy posted 5 days ago
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