Associate Director, Clinical Development Medical Director (MD Required)
Core
Ensures medical and scientific integrity of clinical trials, manages safety data, and leads protocol development for Phase 3/pivotal studies.
Role type
Senior IC clinical development medical director
Builds
Clinical trial protocols, safety reports, and regulatory documentation
Domain
Biopharmaceuticals / Clinical Development
Required skills
Medical degree (MD/DO/MBBS), Clinical research experience (Phase 3), Scientific writing, Safety data management, Protocol design, Regulatory knowledge (ICH/GCP)
Preferred skills
Cardiometabolic disease experience, Industry/CRO experience, AI tool proficiency, Project management
Technologies
SAP, TLFs, BDR, ChatGPT, Microsoft Copilot
Responsibilities
Perform medical monitoring on clinical trials, lead protocol development and amendments, review safety data and SAEs, author Informed Consent Documents, support regulatory filings, manage Data Monitoring Committees
Seniority
Senior, hands-on IC