Medical Director/Senior Medical Director - Dermatology
Core
Provides medical oversight of clinical trials and marketed products to ensure compliance with SOPs, GCP, and regulatory requirements, while offering medical consultation and safety analysis.
Role type
Senior IC Medical Director (Pharmacovigilance/Clinical Trials)
Builds
Clinical trial deliverables (CSRs, safety reports, CTD modules) and marketed product safety dossiers
Domain
Life Sciences / Clinical Research / Pharmacovigilance
Required skills
Medical judgment, safety data analysis, regulatory compliance (FDA/ICH/EMA/GCP), therapeutic expertise, signal detection, report writing
Preferred skills
Active medical licensure, biostatistics knowledge, data management, mentoring
Technologies
Medra, safety databases
Responsibilities
Provide medical review and analysis for serious adverse events and periodic safety reports; Monitor safety variables and review adverse events from clinical studies; Consult with investigators and clients on medical concerns; Assist in writing and reviewing clinical study reports and regulatory documents; Manage signal detection activities and support label updates.
Seniority
Senior, hands-on IC