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 strategy, matrix leadership, safety data interpretation, key opinion leader (KOL) engagement, target product profile (TPP) evaluation, GCP compliance
Preferred skills
Formulation development in neuropsychiatry, fellowship/specialty training in relevant therapeutic area
Technologies
Clinical Study Reports (CSRs), Regulatory submissions, Target Product Profile (TPP)
Responsibilities
Develop and implement clinical development strategy; Design and develop clinical studies and research plans; Manage multiple/complex programs concurrently across clinical lifecycles; Serve as primary clinical representative in regulatory interactions; Lead matrix management of Clinical Trial Physicians and Clinical Scientists
Seniority
Senior Director, strategic leadership & matrix management