Medical Director/Sr Medical Director - Rheumatology
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 (Rheumatology)
Builds
Clinical trial deliverables (CSRs, safety reports, CTD modules) and marketed product dossiers (label updates, risk management plans)
Domain
Life Sciences / Clinical Research / Pharmacovigilance
Required skills
Therapeutic expertise in Rheumatology, Medical judgment for clinical decision-making, Safety data analysis, Regulatory guideline knowledge (FDA, ICH, EMA, GCP), Signal detection, Protocol interpretation
Preferred skills
Active medical licensure, Experience in Contract Research Organizations (CRO) or as Principal Investigator, Experience in Safety/Pharmacovigilance, Mentorship capabilities
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 and protocol restrictions; Assist in writing and reviewing clinical study reports and regulatory documents; Manage signal detection activities and support label updates for marketed products.
Seniority
Senior, hands-on IC with mentorship responsibilities