Clinical Development Director (CDD)
Core
Lead clinical development deliverables and activities for global clinical programs and trials, ensuring data quality, regulatory compliance, and safety reporting.
Role type
Senior IC Clinical Development Director
Builds
Clinical development plans, trial protocols, regulatory submission dossiers, Clinical Study Reports (CSRs), and safety update reports.
Domain
Pharmaceutical industry, clinical research, drug development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial design and methodology, GCP knowledge, statistical analysis methodology, regulatory development process, therapeutic area expertise, people management, stakeholder partnership
Preferred skills
Global matrix environment experience, People management in matrix environment, Global people management
Technologies
Clinical trial management systems, regulatory submission platforms
Responsibilities
Lead delivery of clinical deliverables including development strategies and protocol sections; Conduct ongoing clinical and scientific review of trial data; Prepare inspection readiness and interact with QA; Support safety data monitoring and reporting; Mentor program reports and clinical colleagues; Lead clinical trials as Clinical Scientific Lead when assigned.
Seniority
Senior, hands-on IC with people management
