Executive Medical Director, Clinical Development, Pediatric Neurology

Role Summary

Executive Medical Director responsible for developing and executing the Neurology strategy and driving clinical programs for pediatric neurological diseases, including epilepsy and neurodevelopmental disorders. Serves as clinical or program lead for development of clinical research strategies, development plans, and independent direction of Phase 1–4 studies within cross-functional teams. Provides medical oversight of clinical studies, designs clinical protocols, data collection systems, analyses, and final reports, and collaborates with regulatory, safety, and external partners.

Responsibilities

• Drive strategic direction for neurology programs during development and oversee clinical phases, including design and implementation of clinical plans, data collection, assessment, and communication of results
• Lead the planning and execution of global clinical development projects to meet company objectives in compliance with GXP and regulatory requirements
• Build and maintain relationships with external scientific leaders and investigators
• Report to senior management on strategy, research plans, budgets, and data deliverables
• Support or oversee regulatory submissions in collaboration with cross-functional teams
• Lead or support process improvements to ensure best practices across R&D
• Oversee monitoring procedures and data collection across trials
• Monitor clinical trials through operational teams, QA systems, and CROs
• Contribute to publication and presentation of data externally
• Identify factors or opportunities affecting Neurocrine’s strategies and recommend innovative solutions
• Manage or lead members of the clinical development organization and other functions within a matrix environment

Qualifications

• Required: MD or equivalent with accredited residency and board certification in Pediatric Neurology; at least 8+ years in clinical drug development (Phase 1–3) in pharma/biotech with significant senior leadership experience
• Preferred: Advanced degree (MS, PhD) in a relevant scientific discipline
• Required: Demonstrated success in leading clinical programs in neurology and/or rare diseases; recent experience in pediatric epilepsy and/or neurodevelopmental disorders is desirable
• Preferred: Experience in developing various treatment modalities (small molecules and biologics/genetic therapies)
• Required: Extensive knowledge of clinical drug development, regulatory requirements, study design, biostatistics, GCP, and oversight of internal and CRO resources across early and late development
• Required: Ability to operate in a multi-level matrix environment with internal and external stakeholders
• Required: First-hand clinical and research expertise in neurology; track record of partnering with stakeholders, including scientific organizations and patient advocacy groups
• Required: Broad expertise in leading-edge clinical development, problem-solving, and ability to influence internal/external issues
• Required: Strong analytical, communication, and leadership skills; ability to manage multiple deadlines and lead cross-functional teams