Clinical Development Medical Director, (MD Required)
Core
Provides medical and scientific oversight, data integrity, and quality of clinical trials in Internal Medicine, serving as the primary clinical point of contact with investigators.
Role type
Senior IC Clinical Development Medical Director (Director level)
Builds
Clinical trials for biopharmaceutical products
Domain
Biopharmaceuticals, Internal Medicine
Required skills
Medical degree (MD/DO/MBBS), 4+ years clinical research experience, medical licensing, protocol design, safety data review, regulatory submissions, team leadership
Preferred skills
Cardiometabolic disease experience, scientific productivity, extensive knowledge of ICH/GCP, project management, cross-functional team management
Technologies
Clinical trial management systems, regulatory filing tools
Responsibilities
Provide medical monitoring on clinical trials, lead protocol design and amendments, review safety data and narratives, manage External Data Monitoring Committees, ensure TMF compliance, support audits and inspections, contribute to regulatory filings
Seniority
Senior, hands-on IC with managerial responsibility