Director, Clinical Scientist (Respiratory indications)

Role: Director, Clinical Scientist supporting respiratory programs (asthma and COPD) at late-stage trial phases (Phases 2-3). Responsibilities: lead clinical science on study teams, protocol development, data analysis, regulatory documentation, medical monitoring, site engagement, and trial oversight; contribute to regulatory submissions and publication plans; ensure study quality and inspection readiness. Requirements: PhD, PharmD, MD, MS, or PMP; 9+ years in clinical development with expertise in respiratory indications; strong knowledge of GCP, regulatory guidelines, and trial methodology; experience authoring protocols and regulatory documents; excellent cross-functional collaboration skills. Preferred: experience with biologics, small molecules, AI/ML platforms, and BLA/MAA submissions. HighValue: late-stage respiratory trials (asthma, COPD), clinical development strategy, regulatory support, cross-functional leadership. WorkSetup: remote U.S. with travel to Somerville, MA or Andover, MA as needed.