Clinical Research & Development Director
Core
Drive integrated clinical research and development strategy and execution for autoimmune diseases (inflammatory myopathies, JIA, Sjogren's) to ensure regulatory and market success.
Role type
Director, Clinical Research & Development
Builds
Clinical research studies and drug lifecycle deliverables for AstraZeneca's portfolio
Domain
Biopharmaceuticals, Autoimmune diseases, Cell therapy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic planning, cross-functional leadership, clinical trial oversight, regulatory submission management, budgeting, risk management, CRO contract negotiation, team mentorship, compliance management
Preferred skills
Thought leadership in autoimmune disease, cell therapy expertise, project management certification, change management, global organizational leadership, regulatory defense experience, emerging trend identification
Technologies
GCP/ICH guidelines, regulatory submission platforms
Responsibilities
Develop and align Clinical Research & Development strategies with global goals; Lead execution of clinical studies ensuring scientific rigor and commercial viability; Secure resources and form flexible teams for project progression; Oversee budgeting, timelines, and risk management; Negotiate contracts with CROs and external providers; Drive regulatory submission preparation and defense; Mentor line management and project teams; Ensure compliance with safety, health, and environmental standards
Seniority
Director, strategic leadership & operational execution
