Medical Director, Clinical Science, GI2 TAU- Nephrology
Core
Leads global clinical development strategy and execution for Takeda's pipeline compounds in nephrology, ensuring regulatory approval across US/EU/Japan markets.
Role type
Senior IC Medical Director, Clinical Science
Builds
Global clinical development plans, protocols, and regulatory submissions for pharmaceutical compounds
Domain
Pharmaceutical R&D, Nephrology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global clinical development strategy, multi-regional team leadership, regulatory submission experience (NDA/MAA), medical monitoring, business development due diligence, strategic decision-making
Preferred skills
Nephrology specialization, NDA/MAA/Submission experience, alliance negotiation
Technologies
Clinical development platforms, regulatory submission systems
Responsibilities
Lead global (US/EU/Japan) development teams and establish development strategies; Drive clinical science activities for protocol preparation and study interpretation; Make high-impact go/no-go decisions based on study data; Direct interactions with regulatory authorities and key opinion leaders; Evaluate business development and alliance opportunities; Hire, manage, and mentor clinical staff
Seniority
Senior, hands-on IC with strategic leadership