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. This role includes leading development of clinical research strategies, development plans, and directing Phase 1-4 studies within cross-functional teams. It also covers medical oversight of clinical studies, input on study design, data collection and analysis, and collaboration with external partners and regulatory bodies.

Responsibilities

• Drive strategic direction for neurology programs during development and oversee clinical phases, including design and implementation of clinical plans 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
• Oversee regulatory submission documents in collaboration with cross-functional teams
• Lead process improvement to develop and implement best practices for R&D
• Supervise monitoring procedures and data collection
• Monitor clinical trials through operational teams, QA systems, and CROs
• Contribute to publication and presentation of data externally
• Identify factors that could impact Neurocrine's strategies and propose innovative solutions
• Manage direct or indirect members of the clinical development organization in a matrix environment
• Other duties as assigned

Qualifications

• MD or equivalent degree with accredited residency training and board certification in Neurology; subspecialization (Fellowship trained) preferred and 8+ years of experience in clinical drug development (Phase 1-3) in a pharmaceutical/biotech company, including significant leadership experience
• Advanced degree (MS, PhD) in a relevant scientific discipline preferred
• Demonstrated success in leading clinical programs in neurodegenerative diseases, with recent experience in Alzheimer’s disease and neurocognitive syndromes, Parkinson’s disease, and related disorders
• Experience in developing various treatment modalities (small molecules and biologic/genetic therapies) desired
• Extensive knowledge of clinical drug development, including development planning, regulatory requirements, study design, biostatistics, GCP, and oversight of internal and CRO resources
• Ability to operate in a multi-level matrix environment with internal and external personnel
• First-hand clinical and research expertise in neurology
• Proven ability to partner with stakeholders, collaborators, scientific organizations, and patient advocacy groups
• Broad and comprehensive expertise in leading-edge clinical drug development theories and techniques
• Ingenuity and creativity in problem analysis and resolution for novel situations
• Ability to influence internal/external business and industry issues impacting Neurocrine
• Strong analytical and critical thinking skills to synthesize and communicate complex information
• Ability to set longer-term vision for the department
• Ability to meet multiple deadlines with high quality and efficiency
• Excellent project leadership, communication, and interpersonal skills
• Strong accountability and ability to collaborate and lead in a cross-functional team

Education

• MD or equivalent degree with residency in Neurology; board certification required; fellowship training preferred
• Advanced degree (MS, PhD) in a relevant field preferred