Brief Description
The Director, Clinical Development, will join a growing team in the therapeutic areas of Neuroscience. Responsibilities include clinical leadership of development programs, medical monitoring of clinical trials (if MD), contributing to CNS clinical development strategy, supporting regulatory submissions, and representing clinical development in multidisciplinary teams.
Essential Functions
- Provide leadership and medical/scientific input for clinical programs, clinical protocols (Phase 2/3), clinical study reports, and regulatory documents.
- Serve as medical monitor on CNS/neurology trials (if MD or appropriate per role).
- Provide clinical oversight and make recommendations based on findings.
- Provide strategic input on new product concepts, long-range plans, and licensing opportunities in CNS.
- Collaborate cross-functionally (clinical operations, regulatory affairs, drug safety/pharmacovigilance, quality) to execute Phase 2/Phase 3 trials.
- Collaborate with study investigators on eligibility and subject/patient safety.
- Engage external experts for scientific input.
- Prepare clinical data and clinical program presentations.
- Review/interpret/approve safety and efficacy data for study reports and clinical trial submissions (e.g., IND, NDA).
- Review publication-related materials for sponsored studies.
Required Qualifications/Skills
- Clinical/scientific research experience with neuroscience expertise (epilepsy expertise preferred).
- Experience in pharma/biotech, CRO, or clinical research vendor (preferred).
- Ability to lead cross-functional teams and leverage partnerships.
- Experience preparing regulatory submissions (INDs/NDAs) for US and European agencies; lead clinical portions.
- Excellent oral and written communication.
- Knowledge of GCP, drug safety, MedDRA coding, and pharmacovigilance (as appropriate).
- Collaborative, flexible, proactive, creative problem solving; ability to train physicians/scientists (plus).
- Travel: up to 5β20%.
Education/Licenses
- Medical degree (MD) or advanced degree (PhD/PharmD) with neuroscience drug development experience (epilepsy highly advantageous).
- Board Certification in Neurology (or equivalent CNS training) required; US licensure and/or clinical practice experience preferred.
Application Instructions
- If you are a current Jazz employee, apply via the Internal Career site.