Medical Director, Clinical Science, GI2 TAU- Nephrology
Takeda
July 01, 2026
Remote friendly (Cambridge, MA)
United States
$237,200 - $372,790 USD yearly
Medical Affairs
POSITION OBJECTIVES
- Lead and drive strategy for global (US/EU/Japan) clinical development for assigned Takeda pipeline compounds, integrating medical, scientific, regulatory, and commercial issues.
- Lead multi-disciplinary, multi-regional matrix teams; execute global clinical development plans to support regulatory approval across regions.
- Set strategic direction influencing TGRD/TPC senior leadership decisions.
POSITION ACCOUNTABILITIES
- Lead Global Development Team activities; manage US/EU and Japan development teams; align regional activities to global strategy.
- Establish development strategy and deliverables (Development Strategy, Clinical Development Plan, Clinical Protocols); recommend scope/complexity and influence program budget.
- Monitor and interpret internal/external study data; make high-impact decisions (e.g., go/no-go; protocol or plan modifications).
- Drive clinical science for synopses/protocols/study execution and interpretation; advise clinical scientists; present conclusions to management.
- Lead medical monitoring for protocol conduct and subject safety; oversee non-medical clinical scientists; make final integrity-related study conduct decisions.
- Lead regulatory and key opinion leader interactions; direct preparation of regulatory documents and responses.
- Support due diligence, business development, and alliance projects (feasibility, due diligence, development plan negotiation); serve as clinical contact for alliances.
- Hire, manage, mentor, and develop staff.
QUALIFICATIONS
- MD or internationally recognized equivalent + 5 years clinical research experience (pharma/CRO/consulting/academia).
- Nephrologist preferred.
- Experience leading clinical development/matrix teams across multiple regions.
- NDA/MAA/submission experience preferred.
- Management experience.
SKILLS/KNOWLEDGE
- Superior communication, strategic, interpersonal, negotiating; problem prediction/solving; decision-making in matrix teams; diplomacy.
- Therapeutic area, mechanism-related knowledge; regional/global regulatory requirements; emerging research.
BENEFITS (eligibility, U.S.)
- May include incentives; medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being; up to 80 hours sick time and up to 120 hours paid vacation for new hires.
APPLICATION INSTRUCTIONS
- No phone calls or recruiters please.
- Lead and drive strategy for global (US/EU/Japan) clinical development for assigned Takeda pipeline compounds, integrating medical, scientific, regulatory, and commercial issues.
- Lead multi-disciplinary, multi-regional matrix teams; execute global clinical development plans to support regulatory approval across regions.
- Set strategic direction influencing TGRD/TPC senior leadership decisions.
POSITION ACCOUNTABILITIES
- Lead Global Development Team activities; manage US/EU and Japan development teams; align regional activities to global strategy.
- Establish development strategy and deliverables (Development Strategy, Clinical Development Plan, Clinical Protocols); recommend scope/complexity and influence program budget.
- Monitor and interpret internal/external study data; make high-impact decisions (e.g., go/no-go; protocol or plan modifications).
- Drive clinical science for synopses/protocols/study execution and interpretation; advise clinical scientists; present conclusions to management.
- Lead medical monitoring for protocol conduct and subject safety; oversee non-medical clinical scientists; make final integrity-related study conduct decisions.
- Lead regulatory and key opinion leader interactions; direct preparation of regulatory documents and responses.
- Support due diligence, business development, and alliance projects (feasibility, due diligence, development plan negotiation); serve as clinical contact for alliances.
- Hire, manage, mentor, and develop staff.
QUALIFICATIONS
- MD or internationally recognized equivalent + 5 years clinical research experience (pharma/CRO/consulting/academia).
- Nephrologist preferred.
- Experience leading clinical development/matrix teams across multiple regions.
- NDA/MAA/submission experience preferred.
- Management experience.
SKILLS/KNOWLEDGE
- Superior communication, strategic, interpersonal, negotiating; problem prediction/solving; decision-making in matrix teams; diplomacy.
- Therapeutic area, mechanism-related knowledge; regional/global regulatory requirements; emerging research.
BENEFITS (eligibility, U.S.)
- May include incentives; medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being; up to 80 hours sick time and up to 120 hours paid vacation for new hires.
APPLICATION INSTRUCTIONS
- No phone calls or recruiters please.