POSITION OBJECTIVES:
- Lead and drive strategy for the overall global clinical development of assigned Takeda pipeline compound(s), integrating medical, scientific, regulatory, and commercial issues.
- Lead multi-disciplinary, multi-regional matrix teams through complex decisions to create, maintain, and execute clinical development plans supporting regulatory approval in multiple regions.
- Apply clinical/medical decision-making and influence R&D senior leadership via strategic direction.
ACCOUNTABILITIES:
- Clinical team leadership: Lead clinical teams as Global Clinical Lead/represent Clinical Science; align clinical activities to global strategy.
- Asset/strategy: Lead development of Clinical Development Plans, Clinical Protocols, and key documents; recommend scope/complexity and influence study/program budgets.
- Strategy evaluation: Critically evaluate development strategy; proactively identify challenges and develop contingency plans; recommend high-impact global decisions.
- Data interpretation: Monitor and interpret internal/external study data; assess medical/scientific implications; recommend actions impacting regional/global development (e.g., go/no-go, plan/design modifications).
- Synopsis/protocol and study execution: Oversee Clinical Science for synopses/protocols/study conduct; supervise advisors/supervisees; ensure study design and interpretation.
- Medical monitoring: Oversee medical monitoring, protocol conduct, subject safety, and safety assessment with Pharmacovigilance; ensure scientific integrity.
- External interactions: Lead and negotiate with key opinion leaders; direct clinical scientists on required documents and responses.
- Due diligence/alliance projects: Evaluate business opportunities; conduct scientific/medical feasibility due diligence; lead clinical development planning/negotiation for alliances/in-licensing; interface with partners during ongoing projects.
- Leadership: Interact with research and functions as SME; contribute/lead task forces; hire, mentor, motivate, empower, develop, and retain staff.
EDUCATION/EXPERIENCE:
- MD or internationally recognized equivalent plus 3 years clinical research experience in pharma/CRO/consulting/academia (or combination).
- Prior experience leading matrix teams.
- Nephrology subspecialty.
SKILLS & KNOWLEDGE:
- Superior communication, strategic, interpersonal, negotiating; diplomacy and positive influencing.
- Proactively predicts issues; problem-solving.
- Ability to drive decisions in multi-disciplinary, multi-regional matrix teams.
- Regional/global regulatory requirements; GCP/ICH.
Application instructions:
- Apply via the βApplyβ button.