Executive Medical Director, Clinical Development, Pediatric Neurology

About the role

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 (including clinical operations, preclinical/clinical pharmacology, biometrics, regulatory, drug safety, CMC).
• Responsible for medical oversight of clinical research studies, providing necessary medical input and decisions (in Sponsor medical monitor role) to the 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.
• Collaborates with Research, Preclinical Development, and Experimental Medicine to vet and potentially develop biomarkers necessary for the most effective evaluation of novel molecules.
• Promotes and participates 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, collaborating with other therapeutic areas internally and engaging with external experts as needed to leverage expertise.
• Coordinates and develops content for reports and submissions to regulatory or other agencies.

Requirements

• 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
• Able 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