About The Role:
Executive Medical Director (Neurology) to develop and execute Neurology strategy and drive clinical programs for pediatric neurological diseases (e.g., epilepsy and neurodevelopmental disorders).
Responsibilities:
- Clinical/program lead for development of clinical research strategies, clinical development plans, and independent direction of Phase 1β4 studies within cross-functional teams (clinical operations, preclinical/clinical pharmacology, biometrics, regulatory, drug safety, CMC).
- Medical oversight of clinical research studies (including Sponsor Medical Monitor role), providing medical input/decisions to study teams, partners, and sites.
- Establish/approve scientific methods for clinical protocol design/implementation, data collection, analysis, and final reports.
- Partner with Drug Safety Pharmacovigilance on adverse event reporting and safety monitoring committees.
- Coordinate and develop regulatory and other agency submissions content.
- Participate in Neurology Therapeutic Area Strategy Group; collaborate on R&D strategy, biomarkers, and external innovation assessment.
Your Contributions:
- Drive neurology program direction and oversee clinical phases, plans, data assessment, and results communication.
- Lead global clinical development projects in compliance with GXP and regulatory requirements.
- Build relationships with external scientific leaders/investigators; manage clinical development staff (directly/indirectly) in a matrix environment.
- Lead/oversee regulatory submission documents; support process improvement; monitor trials (directly/indirectly); contribute to external publications/presentations.
Requirements:
- MD (or equivalent) with accredited residency training and board certification in Pediatric Neurology.
- 8+ years clinical drug development (Phase 1β3) in pharma/biotech, including significant senior leadership experience.
- First-hand neurology therapeutic area/research expertise; strong stakeholder partnering.
Preferred:
- MS/PhD in relevant discipline.
- Experience with pediatric epilepsy and/or neurodevelopmental disorders; treatment modalities (small molecules, biologic/genetic therapies).
Skills:
- Deep clinical development knowledge (planning, US/global regulatory requirements, study design, biostatistics, GCP, CRO oversight, report writing, scientific presentation).
- Strong analytical/critical thinking; project leadership; communication; accountability; ability to work in complex matrix environments.
Benefits:
- Annual base salary: $322,800.00β$440,000.00; annual bonus (target 35%); equity long-term incentive eligibility.
- Retirement savings plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and health benefits (medical/prescription/dental/vision).
Application Instructions:
- Apply even if you donβt meet every qualification exactly.