Medical Director, Clinical Science, GI2 TAU- Nephrology
Core
Leads global clinical development strategy and execution for Takeda pipeline compounds in nephrology, ensuring regulatory approval across US, EU, and Japan.
Role type
Senior IC Medical Director (Clinical Science)
Builds
Global clinical development plans, protocols, and regulatory submission strategies for new drug products.
Domain
Pharmaceutical R&D, Nephrology
Required skills
Global clinical development strategy, multi-regional team leadership, regulatory submission experience, medical monitoring, business development due diligence, stakeholder management with KOLs and regulators, strategic decision-making for go/no-go, staff hiring and mentoring.
Preferred skills
Nephrology specialization, NDA/MAA submission experience, prior experience leading matrix teams across multiple regions.
Technologies
Clinical development planning tools, regulatory submission frameworks, data interpretation systems.
Responsibilities
Lead global (US/EU/Japan) development teams and establish development strategies; drive clinical science activities for protocol preparation and study execution; make high-impact global decisions on study design and timelines; direct interactions with regulatory authorities and key opinion leaders; conduct due diligence for business development and alliance projects; hire, manage, and mentor clinical staff.
Seniority
Principal, strategy & mentorship