Medical Director - Sleep Disorders, EMEA
Core
Provide medical leadership and support for clinical trials and safety evaluation within the Pharmacovigilance department, focusing on sleep disorders.
Role type
Senior Medical Director (Sleep Disorders)
Builds
Clinical trial protocols, safety reports, and regulatory submissions for sleep disorder therapies.
Domain
Pharmaceutical industry, Clinical Trials, Pharmacovigilance, Sleep Medicine
Required skills
Medical Doctor specialty in Neurology, Clinical trial protocol design, Medical monitoring, Regulatory guideline knowledge (GCP, NDA), Pediatric Investigation Plan (PIP) experience, Adverse event reporting
Preferred skills
Experience with decentralized clinical trials, Cross-functional team leadership
Technologies
Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs)
Responsibilities
Lead study teams and create clinical trial protocols; Perform real-time medical monitoring of clinical studies; Serve as medical point of contact for internal and external stakeholders; Ensure study compliance with SOPs and GCP; Collaborate with cross-functional teams on medical risks and results.
Seniority
Senior, hands-on IC
