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vendor management budget management clinical operations regulatory ich-gcpπ Description
- Provide strategic and end-to-end operational leadership for global Phase 3 asthma studies.
- Translate program strategy into executable operational plans aligned with regulatory, scientific, and corporate objectives.
- Own study timelines, budgets, resources, quality metrics, and overall delivery.
- Lead cross-functional teams across Clinical Operations, Data Management, Biostatistics, Regulatory, Medical, Quality, and CMC.
- Build and develop a high-performing Clinical Operations team; recruit, hire, onboard, and retain top talent; set performance expectations and coaching for career development.
- Drive process improvements and the adoption of digital tools and patient-focused trial approaches.
π― Requirements
- 12β15+ years of clinical operations experience in pharma/biotech.
- Significant experience leading global Phase 3 studies.
- Proven people management experience including hiring, performance management, and development.
- Strong CRO oversight, global regulatory environments, and inspection readiness.
- Deep working knowledge of ICH/GCP and global clinical development regulations.
- Bachelor's degree required; advanced degree strongly preferred.
π Benefits
- Competitive benefits package.
- Opportunity to contribute to Generative Biology platform and late-stage asthma programs.
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