Senior Medical Director, Clinical Science ,NS TAU- Sleep Medicine
Takeda
August 07, 2026
Remote friendly (Cambridge, MA)
United States
$257,600 - $404,800 USD yearly
Medical Affairs
Senior Medical Director, Clinical Science (Neuroscience) — Cambridge, MA (Hybrid)
Responsibilities / Objectives
- Lead global (US/EU/Japan) clinical development strategy for assigned Takeda pipeline compounds, considering medical, scientific, regulatory, and commercial issues.
- Lead and integrate a multi-disciplinary, multi-regional matrix team to create, maintain, and execute global clinical development plans for regulatory approval across regions.
- Influence senior leadership (TGRD/TPC) by setting strategic direction; drive high-impact “go/no go” decisions and recommendations based on internal/external data.
- Drive clinical science activities: synopses/protocols, study design, interpretation, and presentation of conclusions.
- Perform medical monitoring: protocol conduct and subject safety; oversee safety assessment with Pharmacovigilance.
- Lead external interactions with regulatory authorities and key opinion leaders; develop strategy and materials for regulatory submissions/communications.
- Support business development and alliances: due diligence, feasibility assessment, and negotiation of clinical development plans; serve as clinical contact for alliance projects.
- Hire, manage, mentor, and develop staff.
Qualifications / Skills
- MD (or equivalent) plus 7+ years clinical research experience (pharma/CRO/consulting or academia).
- Proven success leading clinical development/matrix teams across multiple regions.
- Preferred: NDA/MAA/submission experience; management experience.
- Skills: communication, strategic/interpersonal/negotiating; proactive issue prediction and problem-solving; decision-making in matrix teams; diplomacy/influencing.
- Knowledge: therapeutic area/mechanism of action; preferably sleep medicine; regional/global regulatory; GCP/ICH.
Travel
- ~15–25% (driving/flying to meetings; some international).
Application
- Apply via Takeda’s “Apply” process (process begins by clicking Apply).
Responsibilities / Objectives
- Lead global (US/EU/Japan) clinical development strategy for assigned Takeda pipeline compounds, considering medical, scientific, regulatory, and commercial issues.
- Lead and integrate a multi-disciplinary, multi-regional matrix team to create, maintain, and execute global clinical development plans for regulatory approval across regions.
- Influence senior leadership (TGRD/TPC) by setting strategic direction; drive high-impact “go/no go” decisions and recommendations based on internal/external data.
- Drive clinical science activities: synopses/protocols, study design, interpretation, and presentation of conclusions.
- Perform medical monitoring: protocol conduct and subject safety; oversee safety assessment with Pharmacovigilance.
- Lead external interactions with regulatory authorities and key opinion leaders; develop strategy and materials for regulatory submissions/communications.
- Support business development and alliances: due diligence, feasibility assessment, and negotiation of clinical development plans; serve as clinical contact for alliance projects.
- Hire, manage, mentor, and develop staff.
Qualifications / Skills
- MD (or equivalent) plus 7+ years clinical research experience (pharma/CRO/consulting or academia).
- Proven success leading clinical development/matrix teams across multiple regions.
- Preferred: NDA/MAA/submission experience; management experience.
- Skills: communication, strategic/interpersonal/negotiating; proactive issue prediction and problem-solving; decision-making in matrix teams; diplomacy/influencing.
- Knowledge: therapeutic area/mechanism of action; preferably sleep medicine; regional/global regulatory; GCP/ICH.
Travel
- ~15–25% (driving/flying to meetings; some international).
Application
- Apply via Takeda’s “Apply” process (process begins by clicking Apply).