Medical Director - Sleep Disorders
Core
Provide medical oversight of clinical trials and marketed product safety for sleep disorders, ensuring regulatory compliance and supporting business development.
Role type
Associate Medical Director (Sleep Disorders)
Builds
Clinical trial deliverables (CSR, safety reports, CTD modules) and marketed product safety dossiers
Domain
Pharmaceutical industry, Clinical Research, Sleep Medicine
Required skills
Medical Doctor (Neurology), Sleep disorders clinical experience, Clinical trial management, Pharmacovigilance, Safety data analysis, Regulatory guidelines knowledge, NDA submission process
Preferred skills
Pediatric Investigation Plan (PIP) experience, Signal detection activities
Technologies
None stated
Responsibilities
Manage medical aspects of contracted tasks across the pharmaceutical product life-cycle; Provide medical consultation to clients and investigators; Review adverse events and safety data; Assist in writing and reviewing clinical study reports and regulatory documents; Monitor safety variables in clinical studies; Support business development activities.
Seniority
Mid-level, hands-on IC