Senior Director, Early Clinical Development (MD) - Neuroscience
Core
Own the clinical strategy for neuropsychiatry programs, serving as the clinical point of accountability for the Clinical Development Team and responsible for the overall clinical development plan for assets.
Role type
Senior Director, Global Clinical Development (Neuropsychiatry)
Builds
Clinical development plans, regulatory submissions, clinical study reports, and scientific publications for neuropsychiatric drug candidates.
Domain
Pharmaceutical industry, Neuroscience, Neuropsychiatry
Required skills
Clinical trial design and execution, development strategy, regulatory strategy, safety data interpretation, key opinion leader (KOL) engagement, matrix leadership, GCP compliance, dose and schedule definition, biomarker qualification
Preferred skills
Formulation development in neuropsychiatry, fellowship/specialty training in relevant therapeutic area
Technologies
Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), Regulatory Submission Platforms
Responsibilities
Develop and implement clinical development strategy; analyze and interpret clinical trial data; serve as principal functional author for regulatory submissions and clinical study reports; manage multiple complex programs across clinical lifecycles; partner with Worldwide Patient Safety physicians; evaluate strategic options against Target Product Profile (TPP); liaise with scientists to define dose, schedule, and patient selection; present clinical strategy to senior leadership; manage Clinical Trial Physicians and Clinical Scientists.
Seniority
Senior Director, Matrix Leadership