Medical Director/Senior Medical Director - Dermatology
Core
Provides medical oversight of clinical trials and marketed products to ensure compliance with regulations and client directives, offering medical consultation and safety analysis.
Role type
Senior IC Medical Director (Pharmacovigilance/Clinical Trials)
Builds
Clinical trial safety reports, periodic safety reports, labeling updates, and risk management dossiers for pharmaceutical and biotech clients.
Domain
Life Sciences / Clinical Research / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
Medical judgment for clinical trial safety, regulatory compliance (FDA/ICH/GCP), signal detection, adverse event review, therapeutic expertise, data validation, mentorship
Preferred skills
Active medical licensure, experience in Contract Research Organization or as principal investigator, biostatistics knowledge
Technologies
Medra, safety databases
Responsibilities
Monitor safety variables and review adverse events in clinical studies, provide medical consultation to investigators and clients, review and write safety reports (CSR, PSUR, DSUR), manage signal detection activities for marketed products, train team members on protocols and safety issues
Seniority
Senior, hands-on IC with mentorship responsibilities