Director, Clinical Scientist

Responsibilities

• Serve as clinical science lead for respiratory studies (asthma and/or COPD)
• Design and develop clinical trial protocols, clinical study plans, and associated regulatory documents
• Drive development of clinical components for IBs, CSRs, and briefing books
• Participate in medical monitoring to ensure data quality, participant safety, and protocol compliance
• Provide scientific support to investigators and participate in site selection and initiation
• Collaborate with Clinical Operations, Regulatory, Biostatistics, and Safety teams
• Support development of publication plans, abstracts, and manuscripts
• Manage oversight committees such as DSMB and Endpoint Adjudication Committees

Requirements

• Advanced degree (PhD, PharmD, MD, MS, or PMP)
• 9+ years of industry experience in clinical development
• Direct experience in late-stage respiratory studies (asthma and/or COPD)
• Strong knowledge of clinical research methodologies, regulatory guidelines, and GCP
• Proven ability to author clinical protocols, CSRs, and regulatory documents

Preferred Qualifications

• Experience with both 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. By integrating machine learning with large-scale experimentation, the company aims to design proteins with defined biological intent to reduce the uncertainty and cost of developing protein-based medicines.