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Senior Director, Medical Monitor (Respiratory indications)

Generate:Biomedicines
September 03, 2026
Full-time
Remote friendly (United States)
Worldwide
Clinical Research and Development
Role: Senior Director Medical Monitor overseeing late-stage respiratory (asthma and COPD) Phase 3 global clinical trials. Responsibilities: provide medical oversight ensuring patient safety, protocol adherence, data integrity, and inspection readiness; serve as primary clinical contact; contribute to regulatory and clinical documents; support oversight committees; interpret data for regulatory filings and publications; lead cross-functional teams fostering high performance and strategic alignment. Qualifications: MD with board certification in Pulmonology or Allergy & Immunology preferred; 8+ years in biopharma clinical development, especially in asthma and respiratory therapeutics; expertise in trial design, oversight, and execution; strong leadership and communication skills; experience with global regulatory frameworks and successful BLA/MAA submissions is a plus. High-Value: late-stage respiratory biologics, Ph3 trials, global regulatory environment, cross-functional leadership, medical oversight, patient safety, data review, regulatory contributions. WorkSetup: not specified; likely hybrid or remote with international scope.