Executive Medical Director, Clinical Development, Pediatric Neurology

Role Summary

The Executive Medical Director will be primarily responsible for developing and executing the Neurology strategy and driving clinical programs for pediatric neurological diseases like epilepsy and neurodevelopmental disorders. It includes leading clinical research strategies, development plans, and direct oversight of Phase 1-4 studies, with medical input to study teams, external partners, and sites.

Responsibilities

• Drive strategic direction for neurology programs during development and overseeing clinical phases. Responsible for the design and implementation of clinical plans, data collection and assessment, and communication of results
• Lead the planning and execution of clinical development projects globally to achieve company objectives in compliance with GXP and regulatory requirements
• Create and foster strong relationships with external scientific leaders and investigators
• Accountable to senior management in the development of strategies, research plans, budgets, and data deliverables
• Support or oversee as a subject matter expert all relevant US and global regulatory submission documents in collaboration with cross-functional development teams
• Lead and/or support process improvement work to ensure best practices are developed and implemented for R&D organization
• Supervise the organization of monitoring procedures and collection of data
• Monitor clinical trials directly and indirectly through operational teams, QA systems, CROs
• Contribute to publication and presentation of data through scientific communications externally
• Anticipate factors/opportunities that could impact Neurocrine's strategies and its position in the field and recommend new or innovative solutions
• Manage directly or indirectly members of the clinical development organization (MDs, clinical scientists, data scientists) or other functions within a matrix environment
• Other duties as assigned

Qualifications

• MD or equivalent degree with accredited residency training and board certification in Pediatric Neurology 8+ years experience in clinical drug development (Phase 1-3) in a pharmaceutical/biotechnology company, including significant experience in senior leadership role
• Advanced degree (MS, PhD) in relevant scientific discipline preferred
• Demonstrated success in leading clinical programs in neurological and/or rare disease, recent experience in clinical development of drugs for pediatric epilepsy and/or neurodevelopmental disorders desired
• Experience in developing various treatment modalities (small molecules and biologic/genetic therapies) desired
• Extensive knowledge of clinical drug development is mandatory, including knowledge of clinical development planning, US and global regulatory requirements and submission standards, study design, biostatistics, Good Clinical Practice (GCP), comfortable with oversight of internal and CRO resources in study conduct, data collection and analysis, report writing, and scientific presentation of data, across early and late development phases
• Ability to effectively operate in a multi-level matrix corporate environment, requiring interaction with, and/or direction of, internal and external personnel, including physicians, scientists, monitors, administrative, regulatory, commercial, and consultant personnel
• First-hand clinical and research expertise in neurology therapeutic area and diseases
• Recognition and track-record of partnering well with multiple stakeholders, eg, collaboration partners, scientific organizations, and patient advocacy organizations
• Requires broad and comprehensive expertise in leading-edge theories and techniques within clinical drug development
• Applies ingenuity and creativity to problem analysis and resolution in complicated and/or novel situations
• Effectively influences internal/external business and/or industry issues that have an impact on Neurocrine
• Exceptional analytical and critical thinking abilities to synthesize and communicate complex information
• Sets broader picture and longer-term vision for department
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of quality and efficiency
• Excellent project leadership skills to lead across functions and teams
• Excellent presentation, verbal and written communication skills
• Exceptional accountability, interpersonal and organizational skills, and the ability to collaborate and lead effectively in a cross-functional team environment