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data analysis late_stage_trials publication_plans๐ Description
- Serve as clinical science lead for asthma/COPD studies
- Lead late-stage trial design and regulatory submissions
- Design and develop protocols and regulatory documents
- Drive study plans, data reviews, and regulatory docs (IBs/CSRs/briefing books)
- Interpret clinical data with cross-functional teams
- Collaborate across Clinical Ops, Regulatory, Biostatistics, Data Mgmt, and Safety
๐ฏ Requirements
- PhD/PharmD/MD or equivalent required
- Respiratory scientific background preferred
- 9+ years in industry clinical development; late-stage respiratory trials
- Advanced degree and leadership in protocol development and regulatory submissions
- Strong knowledge of GCP, regulatory guidelines, and data-driven decisions
- Excellent leadership and cross-functional collaboration skills
๐ Benefits
- Annual bonus and equity compensation
- Competitive benefits package
- Opportunity to shape respiratory medicine with Generative Biology
- Fast-moving, purpose-driven team
- Remote-friendly work options
- Commitment to equal employment opportunity
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