Director, Clinical Scientist (Respiratory indications)

Role: Director, Clinical Scientist specializing in respiratory programs (asthma and COPD), leading late-stage clinical trials (Phases 2 and 3). Responsibilities: serve as scientific lead on study teams, develop protocols and regulatory documents, support study execution, medical monitoring, and site activities; collaborate with cross-functional teams including Regulatory, Biostatistics, Data Management, and Safety; contribute to publication plans and oversight committees; ensure inspection readiness and high-quality documentation. Requirements: PhD, PharmD, MD, MS, or PMP; 9+ years in industry clinical development, with strong experience in late-stage respiratory trials; expertise in protocol development, GCP, and regulatory guidance; ability to lead clinical science strategy and cross-functional collaboration. Preferred: experience with small molecules or biologics, involvement in BLA/MAA submissions, familiarity with AI/ML-driven drug discovery platforms. High-Value: respiratory indications (asthma, COPD), late-stage development, regulatory documentation, cross-functional leadership, global trial management. Work setup: remote or onsite in Somerville or Andover, MA, with travel as needed.