(Senior) Medical Director - Rheumatology, EMEA (Client - Dedicated)
Core
Provide medical leadership and support for clinical trials and safety evaluation within the Pharmacovigilance department, ensuring medical validity of study endpoints and subject safety.
Role type
Senior Medical Director (Rheumatology)
Builds
Clinical trial protocols, study reports, and safety evaluations for global clinical research.
Domain
Life Sciences / Clinical Research / Pharmacovigilance
Deliverable
client delivery
Required skills
Rheumatology specialty, clinical trial leadership, protocol design and review, medical monitoring, regulatory guideline knowledge, NDA submission process understanding, adverse event reporting expertise
Preferred skills
Experience with decentralized clinical trial services, cross-functional collaboration
Technologies
Clinical trial management systems, regulatory databases
Responsibilities
Create and review clinical trial protocols and amendments; conduct real-time medical monitoring of study subjects; serve as chief liaison between sponsor and internal departments; train investigator sites and CRA staff; ensure study compliance with SOPs and GCP; address medical queries from IRBs and Health Authorities
