Senior Medical Director, Clinical Science ,NS TAU- Sleep Medicine
Takeda
June 26, 2026
Remote friendly (Cambridge, MA)
United States
$257,600 - $404,800 USD yearly
Medical Affairs
OBJECTIVES:
- Lead and drive strategy for global clinical development (US/EU/Japan) for assigned Takeda pipeline compounds, considering medical, scientific, regulatory, and commercial issues.
- Lead multi-disciplinary, multi-regional matrix teams to create, maintain, and execute global clinical development plans to achieve regulatory approval across regions.
- Set strategic direction and influence senior leadership decision-making for projects.
ACCOUNTABILITIES:
- Lead Global Development Team strategy and deliverables (Development Strategy, Clinical Development Plan, Clinical Protocols); recommend scope/complexity and influence program budget.
- Monitor and interpret internal/external study data and make high-impact decisions (e.g., go/no-go; plan/study design modifications) to protect approvability and viability.
- Drive synopsis/protocol development and clinical study execution/interpretation; present conclusions to Management.
- Perform medical monitoring: protocol conduct issues and subject safety; assess safety with Pharmacovigilance; ensure scientific integrity.
- Lead regulatory and KOL interactions; direct development of key documents (e.g., briefing reports) and formal responses.
- Lead due diligence/business development/alliance and in-licensing activities; assess scientific/medical feasibility and strategic fit; serve as clinical contact for alliances.
- Hire, manage, mentor, and retain staff; conduct performance reviews and development planning.
EDUCATION/QUALIFICATIONS:
- MD (or equivalent) plus 7 years clinical research experience in pharma/CRO/consulting/academia; or combination.
- Experience leading clinical development/matrix teams across multiple regions.
- NDA/MAA/submission experience preferred.
- Management experience.
SKILLS/KNOWLEDGE:
- Strong communication, strategic, interpersonal, negotiating, diplomacy, and influencing skills.
- Ability to anticipate issues and solve problems; drive decisions in matrix teams.
- Therapeutic area knowledge relevant to MOA; preferably sleep medicine expertise; regional/global regulatory requirements; GCP/ICH; emerging research.
TRAVEL: ~15–25% (some international).
APPLICATION: Apply via Takeda’s “Apply” button.
- Lead and drive strategy for global clinical development (US/EU/Japan) for assigned Takeda pipeline compounds, considering medical, scientific, regulatory, and commercial issues.
- Lead multi-disciplinary, multi-regional matrix teams to create, maintain, and execute global clinical development plans to achieve regulatory approval across regions.
- Set strategic direction and influence senior leadership decision-making for projects.
ACCOUNTABILITIES:
- Lead Global Development Team strategy and deliverables (Development Strategy, Clinical Development Plan, Clinical Protocols); recommend scope/complexity and influence program budget.
- Monitor and interpret internal/external study data and make high-impact decisions (e.g., go/no-go; plan/study design modifications) to protect approvability and viability.
- Drive synopsis/protocol development and clinical study execution/interpretation; present conclusions to Management.
- Perform medical monitoring: protocol conduct issues and subject safety; assess safety with Pharmacovigilance; ensure scientific integrity.
- Lead regulatory and KOL interactions; direct development of key documents (e.g., briefing reports) and formal responses.
- Lead due diligence/business development/alliance and in-licensing activities; assess scientific/medical feasibility and strategic fit; serve as clinical contact for alliances.
- Hire, manage, mentor, and retain staff; conduct performance reviews and development planning.
EDUCATION/QUALIFICATIONS:
- MD (or equivalent) plus 7 years clinical research experience in pharma/CRO/consulting/academia; or combination.
- Experience leading clinical development/matrix teams across multiple regions.
- NDA/MAA/submission experience preferred.
- Management experience.
SKILLS/KNOWLEDGE:
- Strong communication, strategic, interpersonal, negotiating, diplomacy, and influencing skills.
- Ability to anticipate issues and solve problems; drive decisions in matrix teams.
- Therapeutic area knowledge relevant to MOA; preferably sleep medicine expertise; regional/global regulatory requirements; GCP/ICH; emerging research.
TRAVEL: ~15–25% (some international).
APPLICATION: Apply via Takeda’s “Apply” button.