Director, Clinical Scientist (Respiratory indications)

Generate Biomedicines seeks a Director, Clinical Scientist to lead clinical development for respiratory programs focusing on asthma and COPD. This role involves serving as clinical science lead on Phase 2 and 3 trials, overseeing protocol development, data analysis, regulatory submissions, and cross-functional team collaboration.

Responsibilities

• Serve as clinical science lead on cross-functional teams for Phase 2 and 3 respiratory studies
• Design and develop clinical trial protocols and regulatory documents including statistical analysis plans and case report forms
• Review and interpret clinical data for quality, safety, and protocol compliance; escalate issues appropriately
• Support site selection, initiation, and investigator engagement; address protocol-related inquiries
• Collaborate with Clinical Operations, Regulatory, Biostatistics, and Safety teams for trial execution oversight

Requirements

• Advanced degree (PhD, PharmD, MD, MS, or PMP)
• 9+ years clinical development industry experience
• Direct late-stage respiratory trial experience (asthma and/or COPD)
• Strong knowledge of clinical research methodologies and regulatory guidelines
• Demonstrated ability to lead clinical science strategy in late-stage trials
• Excellent analytical, communication, and cross-functional collaboration skills
• GCP and regulatory submission expertise