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. Specific responsibilities will include: being the clinical or program lead for the development of clinical research strategies, clinical development plans, and independent direction of Phase 1-4 clinical studies collaboratively within cross-functional project teams. Responsible for medical oversight of clinical research studies, providing necessary medical input and decisions to study teams, external partners and clinical sites. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems, data analysis and final reports. Partners with Drug Safety Pharmacovigilance on adverse event reporting and safety monitoring committees as required. Coordinates and develops content for reports and submissions to regulatory or other agencies.

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, including planning, regulatory requirements and submission standards, study design, biostatistics, GCP, oversight of internal and CRO resources, data collection and analysis, report writing, and scientific presentation across early and late development phases
• 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 multiple stakeholders, including collaboration partners, scientific organizations, and patient advocacy groups
• Broad and comprehensive expertise in leading-edge clinical drug development theories and techniques
• Analytical and critical thinking skills to synthesize and communicate complex information
• Ability to manage multiple deadlines across projects with quality and efficiency
• Excellent project leadership, presentation, verbal and written communication skills
• Strong accountability, interpersonal, and organizational skills; ability to collaborate and lead in a cross-functional team

Skills

• Strategic planning for neurology programs
• Clinical development planning and execution
• Regulatory submissions and pharmacovigilance coordination
• Cross-functional leadership and matrix management
• Biomedical data analysis, biostatistics, and clinical reporting
• External collaboration with investigators and scientific leaders
• Communication of complex scientific information

Education

• MD or equivalent with board certification in Pediatric Neurology; advanced degree (MS, PhD) preferred