Senior Director, Medical Monitor (Respiratory indications)
Core
Senior Director Medical Monitor providing medical oversight for late-stage (Phase 3) global clinical trials in asthma and COPD, ensuring patient safety, protocol compliance, and data integrity for novel biologics.
Role type
Senior Director, Medical Monitor (Respiratory)
Builds
Late-stage clinical trials for asthma and COPD using novel biologics
Domain
Biopharma / Respiratory Medicine / Clinical Development
Deliverable
client delivery
Required skills
Medical oversight, protocol compliance, data integrity, subject eligibility review, study query management, protocol deviation assessment, regulatory document review, study committee participation, cross-functional collaboration, clinical data interpretation
Preferred skills
Board certification in Pulmonology or Allergy & Immunology, experience in both large pharma and biotech, familiarity with global regulatory frameworks (FDA, EMA), involvement in BLA/MAA submissions
Technologies
None stated
Responsibilities
Provide day-to-day medical oversight for late-stage clinical trials; Serve as primary medical contact for clinical sites, investigators, and CROs; Review subject eligibility, ongoing data, and study queries; Identify and assess protocol deviations; Contribute to study oversight committees (DSMB, endpoint adjudication); Collaborate with Clinical Operations, Regulatory, Biostatistics, and Pharmacovigilance; Interpret clinical trial data for reports and regulatory filings
Seniority
Senior Director, strategic leadership & hands-on medical oversight
