Senior Medical Director, Clinical Development (Psychiatry)
Core
Lead clinical development for psychiatry products (MDD, bipolar depression) from discovery to Phase 3, serving as Medical Monitor and strategic advisor.
Role type
Senior Medical Director, Clinical Development (Psychiatry)
Builds
Clinical development plans, regulatory submissions (INDs/NDAs), and global clinical trials for neuroscience therapeutics.
Domain
Biopharmaceuticals / Psychiatry / Neuroscience
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical development leadership, Medical Monitor expertise, therapeutic area strategy, regulatory submission drafting, KOL engagement, budget management, team leadership
Preferred skills
Neurology disorder experience, bio-statistics collaboration, in-licensing/out-licensing experience
Technologies
None stated
Responsibilities
Lead and manage clinical development studies in psychiatry; serve as medical monitor for clinical research sites and investigators; contribute to Clinical Development Plans; provide strategic leadership for trial designs; review scientific literature and develop product knowledge; identify and build relationships with KOLs; draft and review regulatory submissions and clinical documents; interpret clinical trial data; present proposals to executive leadership; recruit and evaluate direct reports.
Seniority
Senior, hands-on IC with leadership responsibilities