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, and scientific publications for neuropsychiatric drug candidates.
Domain
Neuroscience / Neuropsychiatry / Clinical Development
Required skills
Clinical trial design and execution, development strategy, regulatory interactions, matrix leadership, safety data interpretation, key opinion leader (KOL) engagement, dose and schedule definition, patient selection criteria.
Preferred skills
Formulation development in neuropsychiatry, fellowship/specialty training in relevant therapeutic area.
Technologies
Clinical Study Reports (CSRs), Regulatory submissions, Target Product Profile (TPP), GCP compliance tools.
Responsibilities
Develop and implement clinical development strategy; serve as Clinical Trial Physician; manage multiple complex programs across clinical lifecycles; act as primary clinical representative in regulatory interactions; establish relationships with key investigators and academic centers; mentor and manage Clinical Trial Physicians and Clinical Scientists.
Seniority
Senior Director, strategic leadership & matrix management