Senior Director, Medical Monitor (Respiratory indications)

📋 Description

• Oversee late-stage asthma/COPD trials for safety, protocol compliance, and data integrity
• Act as primary medical contact for sites, investigators, and CROs; review eligibility
• Member of Clinical Development, Safety Management, and Study Execution teams
• Contribute to core clinical/regulatory documents (IB, ICF, RFI, protocols, DSUR)
• Support oversight committees (DSMB, endpoint adjudication); collaborate with Clinical Ops, Regulatory, Biostatistics, Pharmacovigilance
• Interpret trial data and contribute to study reports and regulatory filings

🎯 Requirements

• MD with board certification in Pulmonology or Allergy & Immunology preferred
• 8+ years clinical development experience in biopharma
• Extensive expertise in asthma and respiratory trial design, oversight, execution
• Strong cross-functional leadership and communication skills
• MD required; additional scientific training (fellowship/MPH) a plus
• Nice to have: experience in large pharma/biotech; familiarity with FDA/EMA; prior BLA/MAA submissions

🎁 Benefits

• Annual bonus
• Equity compensation
• Competitive benefits package