Senior Director, Medical Monitor (Respiratory indications)
Core
Provide 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 respiratory biologics
Domain
Biopharma / Respiratory Medicine / Clinical Development
Deliverable
client delivery
Required skills
Medical oversight of clinical trials, protocol compliance, data integrity, subject eligibility review, study query management, protocol deviation assessment, regulatory document authorship/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 settings, familiarity with global regulatory frameworks (FDA, EMA), prior involvement in BLA or 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; Serve as a member of the Clinical Development, Safety Management and Study Execution teams; Contributing author and key reviewer of core clinical and regulatory documents; Support study oversight committees; Interpret clinical trial data and contribute to study reports, regulatory filings, and publications; Hold teams to high standards for technical and collaborative performance
Seniority
Senior Director, strategic leadership & hands-on medical oversight
