Director, Clinical Scientist (Respiratory)

The role

The Director, Clinical Scientist will support the development of respiratory programs focusing on asthma and COPD. This person will serve as the clinical science lead on cross-functional study teams for Phase 2 and 3 trials.

What you will do

• Serve as clinical science lead for respiratory studies
• Support day-to-day study execution
• Design and develop clinical trial protocols and associated documents
• Drive development of clinical components of regulatory documents
• Participate in medical monitoring activities
• Participate in site selection, initiation, and ongoing engagement
• Contribute to trial execution and oversight as a member of the clinical operations study delivery team
• Collaborate with Clinical Operations, Regulatory, Biostatistics, Data Management, and Safety teams
• Contribute to internal governance meetings
• Ensure inspection readiness

Required qualifications

• Advanced degree (PhD, PharmD, MD, MS, 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, regulatory guidelines, and GCP
• Demonstrated ability to lead clinical science strategy and execution in late-stage trials
• Excellent analytical, communication, and cross-functional collaboration skills
• Prior experience authoring clinical protocols, CSRs, and regulatory documents

Nice to have

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

Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package

About the company

Generate:Biomedicines is a clinical-stage generative biology company pioneering the AI revolution in drug design and development. The company integrates machine learning with large-scale experimentation to design proteins with defined biological intent.