Senior Director, Global Clinical Development, Neuroscience
Core
Lead global clinical development plans, trial design, and execution for neurodegenerative and neuropsychiatric assets.
Role type
Senior Director, Global Clinical Development (Neuroscience)
Builds
Clinical development plans, regulatory submissions, study reports, and publications for new drug candidates.
Domain
Pharmaceutical / Neuroscience (Neurodegenerative & Neuropsychiatric)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical development strategy, trial design and execution, regulatory submission authoring, matrix leadership, KOL engagement, safety data review, biomarker qualification, dose/schedule definition, strategic option evaluation
Preferred skills
Basic research expertise in neurodegeneration/neuropsychiatry, fellowship/specialty training in therapeutic area, track record in publications/patents/keynote speaking
Technologies
GCP, regulatory submission systems, clinical trial management systems
Responsibilities
Serve as clinical point of accountability for asset(s); articulate clinical development strategy; design and develop clinical studies; manage complex active programs across lifecycles; serve as independent Medical Monitor; act as primary clinical representative in regulatory interactions; establish alliances with academic centers and vendors; lead and mentor Clinical Trial Physicians and Clinical Scientists
Seniority
Senior Director, strategic leadership & matrix management