Senior Director, Medical Monitor (Respiratory indications)

The role

This person will provide medical oversight for late-stage respiratory clinical trials in asthma and COPD. They will ensure patient safety, protocol compliance, and data integrity while serving as a primary medical contact for sites and investigators.

What you will do

• Provide day-to day medical oversight for late-stage clinical trials in asthma and/or COPD
• Serve as primary medical contact for clinical sites, investigators, and CROs
• Perform subject eligibility review, ongoing data reviews, manage study queries, and identify and assess protocol deviations
• Serve as a member of the Clinical Development, Safety Management and Study Execution teams
• Contribute as author and reviewer of core clinical and regulatory documents
• Support study oversight committees including DSMB and endpoint adjudication committee
• Collaborate cross-functionally with Clinical Operations, Regulatory, Biostatistics, and Pharmacovigilance
• Interpret clinical trial data and contribute to study reports, regulatory filings, and publications
• Hold teams to high standards for technical and collaborative performance
• Foster a high-performing, diverse, and inclusive team culture

Required qualifications

• MD
• 8+ years of clinical development experience in the biopharma industry
• Extensive expertise in asthma and respiratory clinical trial design, oversight, and execution
• Strong cross-functional leadership and communication skills
• Proven ability to collaborate with internal teams and external stakeholders

Nice to have

• board certification in Pulmonology or Allergy & Immunology
• additional scientific training (e.g., fellowship, MPH)
• Experience in both large pharma and biotech settings
• Familiarity with global regulatory frameworks (e.g., FDA, EMA)
• Prior involvement in successful BLA or MAA submissions

Benefits

• annual bonus
• equity compensation
• competitive benefits package

Before you apply

• Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates

About the company

Generate:Biomedicines is a clinical-stage generative biology company pioneering the AI revolution in drug design and development. They are advancing a new approach to drug creation by integrating machine learning with large-scale experimentation.