Senior Director, Medical Monitor (Respiratory indications)
Generate Biomedicines · Remote
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Role summary
Generate Biomedicines seeks an MD with deep respiratory expertise to oversee late-stage clinical trials in asthma and COPD. The Senior Director Medical Monitor will manage Ph3 global studies, ensure patient safety and protocol compliance, and collaborate across clinical development, regulatory, and safety teams.
What they're looking for
- MD degree required
- 8+ years biopharma clinical development experience
- Board certification in Pulmonology or Allergy & Immunology preferred
- Extensive expertise in asthma and respiratory clinical trial design and oversight
- Strong cross-functional leadership and communication skills
- Proven ability to collaborate with internal and external stakeholders
What you'll be doing
- Provide medical oversight for Ph3 asthma and COPD trials, ensuring patient safety, protocol compliance, and data integrity
- Serve as primary medical contact for clinical sites, investigators, and CROs; perform eligibility reviews and manage study queries
- Contribute to and review clinical and regulatory documents including study protocols, IB, ICF, and DSUR
- Support oversight committees including DSMB and endpoint adjudication; interpret trial data for study reports and regulatory filings
- Lead teams to high standards of performance, foster inclusive culture, and communicate with clarity across functions
Privacy & handoff
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