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.

Responsibilities

• Be 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 (including clinical operations, preclinical/clinical pharmacology, biometrics, regulatory, drug safety, CMC).
• Provide medical oversight of clinical research studies, delivering necessary medical input and decisions (Sponsor medical monitor role) to study teams, external partners and clinical sites.
• Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems, data analysis and final reports.
• Partner with Drug Safety Pharmacovigilance on adverse event reporting and safety monitoring committees as required.
• Coordinate and develop content for reports and submissions to regulatory or other agencies.
• Participate in the cross-functional Neurology Therapeutic Area Strategy Group to develop and evolve R&D strategy on new targets, research programs and platform development to support existing and emerging neurology programs.
• Collaborate with Research, Preclinical Development, and Experimental Medicine to vet and potentially develop biomarkers for effective evaluation of novel molecules.
• Partner with Business Development in the assessment of external innovation.

Qualifications

• MD or equivalent degree with accredited residency training and board certification in Pediatric Neurology; 8+ years of experience in clinical drug development (Phase 1-3) in a pharmaceutical/biotechnology company, including senior leadership experience
• Advanced degree (MS, PhD) in a relevant scientific discipline preferred
• Demonstrated success in leading clinical programs in neurological and/or rare disease; recent experience in pediatric epilepsy and/or neurodevelopmental disorders desired
• Experience in developing multiple 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
• Clinical and research expertise in neurology; experience partnering with researchers, scientific organizations, and patient advocacy groups
• Strong analytical and critical thinking abilities; ability to synthesize and communicate complex information
• Strong leadership, project management, and communication skills

Skills

• Strategic planning for neurology programs
• Global clinical development project leadership
• Stakeholder relationship management
• Regulatory submission support
• Process improvement in R&D
• Monitoring procedures and data collection oversight
• Clinical trial monitoring and QA/system oversight
• Scientific communication and publication
• External collaboration and partnership development

Education

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

Additional Requirements

• None listed