Related skills
gcp regulatory clinical development csrs case report forms📋 Description
- Serve as clinical science lead for respiratory studies (asthma and COPD)
- Drive protocol development, data analysis, and regulatory documents
- Design protocols, CRFs, and SAPs; oversee database design
- Medical monitoring: review data for quality and safety
- Site initiation and ongoing investigator engagement; oversee CROs/vendors
- Support regulatory submissions, governance, and publication plans
🎯 Requirements
- Advanced degree (PhD/MD/PharmD) and 9+ years in clinical development
- Deep knowledge of clinical research, regulatory guidelines, and GCP
- Proven ability to lead late-stage respiratory trial strategy and execution
- Excellent analytical, communication, and cross-functional skills
- Experience authoring protocols, CSRs, and regulatory documents
- Nice to have AI/ML‑driven drug discovery platforms experience
🎁 Benefits
- Comprehensive benefits package
- Inclusive, high-performing team culture with mentorship
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