Clinical Scientific Director
Takeda
August 23, 2026
Remote friendly (Cambridge, MA)
United States
$177,000 - $278,080 USD yearly
Clinical Research and Development
Position Objectives
- Drive/contribute to strategy for clinical studies within global clinical development for assigned Takeda pipeline compound(s), considering medical, scientific, regulatory, and commercial issues.
- Lead development decisions integrating cross-discipline input to create/maintain/execute studies in the clinical development plan to support regulatory approval in multiple regions.
- Apply clinical decision-making to clinical development issues and influence Neuroscience TA leadership via strategic direction.
Key Accountabilities
- Represent Clinical Science on study execution and clinical teams; support alignment to global strategy.
- Contribute to global project/clinical subteam strategy and deliverables (asset strategy, clinical development plan, protocols).
- Recommend study scope/complexity/size and influence budgets.
- Monitor/interpret internal and external study data; make recommendations impacting regional/global development (e.g., go/no-go, plan/study design modifications).
- Ensure scientific rigor/integrity and high-quality data; lead other functional representatives to optimize data quality.
Synopses/Protocols, Data Monitoring, External Interactions, Alliances
- Oversee/contribute to synopses/protocol preparation/approval, study conduct, and interpretation.
- Monitor protocol conduct, data quality/integrity, participant well-being; assess safety with Medical Director/Pharmacovigilance.
- Lead/contribute to investigator/KOL interactions; develop regulatory/IRB-related documents and incorporate advice into study design.
- Support due diligence and alliance/partner clinical development activities.
Qualifications/Skills
- Advanced life science degree + 3 years clinical research (pharma/CRO/consulting or academic biomedical/clinical experience); or bachelor’s + 5+ years.
- Superior communication, strategic/interpersonal/negotiating skills; proactive issue prediction/problem-solving.
- Ability to drive decisions in multi-disciplinary, multi-regional matrix teams; diplomacy and positive influence.
- Knowledge desired: Neurology; regional/global regulatory requirements; GCP/ICH.
Travel: ~10–20%.
Benefits (if applicable to role/location): eligible for medical/dental/vision, 401(k) match, disability/life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time and up to 120 hours paid vacation for new hires.
- Drive/contribute to strategy for clinical studies within global clinical development for assigned Takeda pipeline compound(s), considering medical, scientific, regulatory, and commercial issues.
- Lead development decisions integrating cross-discipline input to create/maintain/execute studies in the clinical development plan to support regulatory approval in multiple regions.
- Apply clinical decision-making to clinical development issues and influence Neuroscience TA leadership via strategic direction.
Key Accountabilities
- Represent Clinical Science on study execution and clinical teams; support alignment to global strategy.
- Contribute to global project/clinical subteam strategy and deliverables (asset strategy, clinical development plan, protocols).
- Recommend study scope/complexity/size and influence budgets.
- Monitor/interpret internal and external study data; make recommendations impacting regional/global development (e.g., go/no-go, plan/study design modifications).
- Ensure scientific rigor/integrity and high-quality data; lead other functional representatives to optimize data quality.
Synopses/Protocols, Data Monitoring, External Interactions, Alliances
- Oversee/contribute to synopses/protocol preparation/approval, study conduct, and interpretation.
- Monitor protocol conduct, data quality/integrity, participant well-being; assess safety with Medical Director/Pharmacovigilance.
- Lead/contribute to investigator/KOL interactions; develop regulatory/IRB-related documents and incorporate advice into study design.
- Support due diligence and alliance/partner clinical development activities.
Qualifications/Skills
- Advanced life science degree + 3 years clinical research (pharma/CRO/consulting or academic biomedical/clinical experience); or bachelor’s + 5+ years.
- Superior communication, strategic/interpersonal/negotiating skills; proactive issue prediction/problem-solving.
- Ability to drive decisions in multi-disciplinary, multi-regional matrix teams; diplomacy and positive influence.
- Knowledge desired: Neurology; regional/global regulatory requirements; GCP/ICH.
Travel: ~10–20%.
Benefits (if applicable to role/location): eligible for medical/dental/vision, 401(k) match, disability/life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time and up to 120 hours paid vacation for new hires.