Senior Medical Director, Clinical Development - Neurodegeneration

About the role

The Senior Medical Director, Clinical Development, Neurodegeneration will lead clinical development strategy, oversee clinical trials, and drive regulatory submissions for neurodegenerative disease, particularly Alzheimer’s Dementia.

Responsibilities

• Lead clinical development strategy and clinical matrix team (CMT)
• Ensure cohesive and comprehensive clinical development plans (CDP) for product(s) and/or indication(s)
• Identify and highlight transformational opportunities
• Contribute to development of the Integrated Evidence Strategy (IES)
• Drive clinical development timelines for complex assets
• Manage technical and leadership development of Clinical Development staff
• Lead clinical development discussions and teams at global regulatory interactions
• Draft clinical components of global regulatory submissions/files
• Promote innovative methodologies and processes

Qualifications

• Medical degree and clinical medical specialty training board qualification/registration
• Experience in the global pharmaceutical/biotechnology industry in the field of Neurodegeneration
• Experience in clinical research and drug development, with a focus on Alzheimer’s Dementia
• Experience in leading NDA, BLA, or MAA submissions and managing global clinical trials in the field of neurodegenerative disease
• Experience of clinical research methodology and principles of biostatistics to facilitate innovative and efficient designs of clinical trials and clinical development plans with clear data-driven decision rules
• Matrix team leadership experience within a clinical development setting