Medical Director/Sr Medical Director - Cardiology(Remote)
Core
Provide medical oversight of clinical trials and marketed products, ensuring compliance with regulations and client directives while managing safety data and therapeutic expertise.
Role type
Senior Individual Contributor Medical Director (Cardiology)
Builds
Clinical trial deliverables, safety reports, regulatory dossiers, and risk management activities for pharmaceutical clients
Domain
Life Sciences / Clinical Research / Pharmacovigilance
Deliverable
client delivery
Required skills
Cardiology clinical expertise, clinical trial management, safety/pharmacovigilance experience, regulatory compliance (FDA/ICH/EMA/GCP), medical review of adverse events, signal detection, therapeutic training
Preferred skills
Active medical licensure, experience as principal investigator, biostatistics knowledge, data management proficiency
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 clinical study reports and regulatory documents, manage signal detection and risk management activities, train team members on protocols and safety issues
Seniority
Senior, hands-on IC with mentorship responsibilities