Senior Director, Clinical Development Medical Lead (Asthma and COPD)
Related skills
regulatory submissions md pulmonology asthma copd📋 Description
- Lead late-stage asthma/COPD trials; provide medical monitoring.
- Medical leadership for global asthma/COPD trials focusing on safety and rigor.
- Develop clinical strategies and TPPS for asthma and COPD.
- Oversee study design, protocols, data review, and safety monitoring.
- Primary medical contact for sites/investigators/CROs; cross-functional.
- Engage external experts/health authorities to support programs.
🎯 Requirements
- MD required; Pulmonology or Allergy & Immunology board preferred.
- 8+ years in biopharma clinical development; asthma/respiratory expertise.
- Proven track record leading late-stage asthma/COPD trials and safety.
- Regulatory submissions/interactions with FDA/EMA; BLA/MAA familiarity.
- Expertise in protocol development, clinical strategies, and TPPs.
- Strong cross-functional leadership and communication.
🎁 Benefits
- Annual bonus, equity compensation, and a competitive benefits package.
- Shape asthma care through Generative Biology.
- Collaborative, mission-driven team focused on science.
- Remote-friendly work environment.
- Professional development and leadership growth opportunities.
- Access to external experts and advisory interactions.
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