Director, Clinical Scientist

Responsibilities

• Serve as clinical science lead for respiratory studies focusing on asthma and COPD
• Design and develop clinical trial protocols, study plans, and data review plans
• Drive development of clinical components for regulatory documents including IBs and CSRs
• Perform medical monitoring activities to ensure data quality and participant safety
• Provide scientific support to investigators and manage site engagement
• Collaborate with Clinical Operations, Regulatory, Biostatistics, and Safety teams
• Support development of publication plans, abstracts, and manuscripts
• Contribute to TPPs and clinical development plans

Requirements

• Advanced degree (PhD, PharmD, MD, MS, or PMP)
• 9+ years of industry experience in clinical development
• Direct experience in late-stage respiratory (asthma and/or COPD) studies
• Strong knowledge of clinical research methodologies and GCP
• Proven ability to lead clinical science strategy in late-stage trials

Preferred Qualifications

• Experience with small molecule and biologic modalities
• Familiarity with AI/ML-driven drug discovery platforms
• Previous involvement in BLA or MAA submissions

About the Company

Generate:Biomedicines is a clinical-stage generative biology company pioneering the AI revolution in drug design and development, integrating machine learning with large-scale experimentation to create protein-based medicines.