Senior Director, Medical Monitor

Responsibilities

• Provide day-to-day medical oversight for late-stage clinical trials in asthma and/or COPD
• Ensure patient safety, protocol compliance, data integrity, and inspection readiness
• Serve as primary medical contact for clinical sites, investigators, and CROs
• Perform subject eligibility review, ongoing data reviews, and manage study queries
• Contribute as an author and reviewer for core clinical and regulatory documents (IB, ICF, RFI, study protocols, DSUR)
• Support study oversight committees including DSMB and endpoint adjudication committees
• Collaborate cross-functionally with Clinical Operations, Regulatory, Biostatistics, and Pharmacovigilance
• Interpret clinical trial data for study reports, regulatory filings, and publications

Requirements

• MD degree required
• 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

Preferred Qualifications

• Board certification in Pulmonology or Allergy & Immunology
• Additional scientific training such as a fellowship or MPH
• Experience in both large pharma and biotech settings
• Familiarity with global regulatory frameworks (FDA, EMA)
• Prior involvement in successful 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, time, and cost of developing protein-based medicines.