Executive Medical Director, Clinical Development, Neurodegeneration

Role Summary

The Executive Medical Director will be primarily responsible for developing and executing the Neurology strategy and driving clinical programs for neurodegenerative diseases. Responsible for medical oversight of clinical research studies, designing and implementing clinical protocols, and collaborating across cross-functional teams to advance Phase 1-4 programs.

Responsibilities

• Drive strategic direction for neurology programs during development and oversee clinical phases, including design and implementation of clinical plans, data collection and assessment, and communication of results
• Lead planning and execution of global clinical development projects in compliance with GXP and regulatory requirements
• Foster relationships with external scientific leaders and investigators
• Report to senior management on strategies, research plans, budgets, and data deliverables
• Provide SME input for US and global regulatory submission documents in collaboration with cross-functional teams
• Lead or support process improvement to implement best practices in R&D
• Oversee monitoring procedures and data collection
• Monitor clinical trials through operational teams, QA systems, and CROs
• Contribute to publications and presentations of data externally
• Anticipate factors affecting Neurocrine's strategies and suggest innovative solutions
• Manage members of the clinical development organization within a matrix environment
• Other duties as assigned

Qualifications

• MD or equivalent with neurology board certification; subspecialization preferred; 8+ years in clinical drug development (Phase 1-3) with senior leadership experience
• Advanced degree (MS, PhD) preferred
• Proven success in leading neurodegenerative disease programs, with recent experience in Alzheimer‚Äôs, neurocognitive syndromes, Parkinson‚Äôs and related disorders
• Experience with multiple modalities (small molecules, biologics/genetic therapies) desired
• Extensive knowledge of clinical drug development, regulatory requirements, study design, biostatistics, GCP, and oversight of internal/CRO resources
• Ability to operate in a multi-level matrix environment with diverse stakeholders
• Clinical and research expertise in neurology; strong collaboration with partners, scientific organizations, and patient advocacy groups
• Broad expertise in leading-edge clinical development theories and techniques
• Creative problem-solving, strong influence on internal/external business, and excellent analytical thinking
• Vision for department and ability to meet multiple deadlines with high quality
• Excellent project leadership, presentation, verbal and written communication skills
• Strong accountability, interpersonal, and organizational skills for cross-functional leadership

Skills

• Strategic program development
• Cross-functional collaboration
• Regulatory submissions
• Clinical trial oversight
• Data analysis and interpretation
• Scientific communication
• Biomarkers and translational science (preferred)

Education

• MD or equivalent; board certification in Neurology; Fellowship preferred
• MS/PhD in a relevant scientific discipline preferred

Additional Requirements

• No explicit travel or physical requirements specified