(Senior) Medical Director - Dermatology/ Allergology/ Immunology, EMEA (Client-Dedicated)
Core
Provide medical leadership and safety evaluation for Dermatology clinical trials within the PPD Pharmacovigilance department.
Role type
Senior Medical Director (Clinical Trials)
Builds
Clinical trial protocols, study reports, and safety evaluations for pharmaceutical clients.
Domain
Pharmaceutical industry, Clinical Research, Dermatology/Allergology/Immunology
Deliverable
client delivery
Required skills
Medical leadership, protocol design and review, medical monitoring, regulatory guideline application, stakeholder liaison, SOP/GCP compliance
Preferred skills
NDA submission process experience, adverse event reporting expertise, hospital setting experience
Technologies
Clinical trial management systems, regulatory databases
Responsibilities
Create clinical trial protocols and amendments; conduct real-time medical monitoring for study validity and subject safety; serve as chief liaison between sponsor and internal departments; train investigator sites and CRAs on protocol procedures; ensure study compliance with medical SOPs and GCP; collaborate with cross-functional teams on medical risks and results.
Seniority
Senior, hands-on IC
