Medical Director/Senior Medical Director - Endocrinology(Remote U.S)
Core
Provides medical oversight of clinical trials to ensure safety profiles, regulatory compliance, and accurate medical content for drug development.
Role type
Senior Medical Director (Endocrinology)
Builds
Clinical trial safety data, regulatory reports, and medical content for new drug approvals
Domain
Pharmaceutical / Clinical Research / Endocrinology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
Medical oversight of clinical trials, safety variable monitoring, adverse event review, regulatory guideline knowledge (FDA/ICH/GCP), therapeutic expertise in Endocrinology, data review and validation, signal detection, report writing (CSR/IND/NDA)
Preferred skills
Active medical licensure, clinical development/medical monitoring experience, pharmacovigilance experience, mentorship capabilities
Technologies
Medra, safety databases
Responsibilities
Manage signal detection activities and support dossier maintenance, medically review adverse events and serious adverse events, discuss medical concerns with principal investigators, assist in writing and reviewing clinical study reports and regulatory documents, ensure delegated tasks to medical monitors are executed per regulations
Seniority
Senior, hands-on IC with mentorship