Medical Director, Clinical Science, Neuroscience TAU- Psychiatry
Core
Leads global clinical development strategy and execution for neuroscience-psychiatry pipeline compounds across US/EU/Japan/China to achieve regulatory approval.
Role type
Senior IC Medical Director (Clinical Science)
Builds
Global clinical development plans, protocols, and regulatory submission dossiers for new medicines
Domain
Pharmaceutical R&D, Neuroscience, Psychiatry
Required skills
Global clinical development strategy, multi-regional team leadership, Phase 3 study management, regulatory submission experience, medical monitoring, business development due diligence
Preferred skills
NDA/MAA submission experience, alliance negotiation
Technologies
Clinical development platforms, regulatory databases
Responsibilities
Lead global development teams and set strategic direction for assigned compounds; Establish and drive clinical development plans and protocols; Make high-impact go/no-go decisions based on study data; Monitor study conduct and subject safety; Interact with regulatory authorities and key opinion leaders; Evaluate business development and alliance opportunities
Seniority
Senior, hands-on IC with management responsibilities