Medical Director - All European Countries
Core
Primary medical and scientific expert for clinical trial protocols and Expanded Access Programs (EAPs), ensuring accuracy, integrity, and successful execution of studies.
Role type
Senior Medical Director (Clinical Research)
Builds
Clinical trial protocols, EAPs, and safety oversight mechanisms
Domain
Clinical Research / Pharmaceutical Development
Required skills
Medical Doctor (MD) degree, 5+ years clinical research experience, protocol development and interpretation, safety monitoring, adverse event reporting, clinical trial design knowledge, regulatory requirements knowledge, leadership, data analysis
Preferred skills
EAP/CUP/NPP experience, international travel capability
Technologies
Microsoft Office (Excel, Word, PowerPoint)
Responsibilities
Serve as primary medical point of contact for investigators and regulatory agencies; Monitor clinical trials and EAPs for safety and compliance; Lead investigator calls for site selection and patient recruitment; Review and report safety events (AEs, SAEs); Provide causality assessments; Work with DSMBs for safety oversight; Deliver training to investigators and staff; Lead protocol development and treatment guidelines; Oversee protocol adherence and manage deviations.
Seniority
Senior, hands-on IC