Related skills
leadership regulatory filings clinical operations vendor governance cro management📋 Description
- Own the strategy and delivery of clinical operations across trials.
- Lead global Phase I-III programs and registrational readiness.
- Partner cross-functionally with Regulatory, Biometrics, Medical Affairs.
- Optimize trials for cost, speed, and scientific quality.
- Build and manage internal staff, vendors, and CRO partnerships.
- Drive innovation in trial execution and data delivery.
🎯 Requirements
- Bachelor's degree in life sciences; advanced degree preferred.
- 15+ years in biotech/pharma clinical ops
- 8+ years in direct people leadership roles
- Proven leader of Phase I-III trials including patient studies
- Respiratory trials experience is preferred
- Regulatory filings (IND/NDA/MAA) with FDA/EMA
- Strong cross-functional leadership and vendor governance
🎁 Benefits
- Competitive benefits package
- Equity compensation
- Global, cross-functional collaboration
- Opportunity to shape Generative Biology medicines
- Remote-friendly environment
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