Senior Medical Director, Clinical Science -Solid Tumor
Takeda
8 hours ago
Remote friendly (Boston, MA)
United States
$257,600 - $404,800 USD yearly
Clinical Research and Development
Senior Medical Director, Solid Tumor
Objectives
- Lead and drive strategy for global (US/EU/Japan) clinical development for multiple pipeline compounds, integrating medical, scientific, regulatory, and commercial issues.
- Lead multi-disciplinary, multi-regional matrix teams and create, maintain, and execute global clinical development plans to support regulatory approval in multiple regions.
- Set strategic direction influencing TGRD and TPC senior leadership decision-making.
Accountabilities
- Clinical Development team participation and leadership:
- Lead Global Development Team (US, EU, Japan) for assigned compounds; manage US/EU and Japan development teams (directly or via clinical scientist leadership).
- Direct development strategy and deliverables (Development Strategy, Clinical Development Plan, Clinical Protocols); recommend program scope/complexity impacting budgets.
- Monitor and interpret internal/external study data; make high-impact global “go/no go” and development plan/study design recommendations impacting timelines and labeling.
- Synopsis/Protocol development, study execution, and interpretation:
- Drive Clinical Science activities for synopses and protocols; advise clinical scientists; ensure successful completion of objectives with proactive contingency planning.
- Interpret data medically and scientifically, including relevance to individual patients.
- Trial Medical Monitoring:
- Oversee medical monitoring, assessing protocol conduct and subject safety; evaluate safety information with Pharmacovigilance.
- External interactions:
- Lead interactions with regulatory agencies and key opinion leaders; serve as advisor to clinical scientists and accountable to senior leadership for objectives.
- Due diligence, business development, and alliances:
- Identify/evaluate business development opportunities; conduct due diligence; develop and negotiate clinical development plans for alliances/in-licensing.
- Assess scientific/medical/development feasibility and strategic portfolio fit; represent clinical science on internal assessment teams.
- Serve as clinical contact for alliance projects; interface with partners and guide clinical scientists.
- Leadership/task force participation:
- Act as clinical science SME; represent clinical science on high-impact/priority task forces; lead internal and global cross-functional teams.
- Hire, manage, mentor, develop, and retain staff; conduct performance reviews, goal setting, and development planning.
Education/Experience/Qualifications
- MD (or internationally recognized equivalent) plus 7 years of clinical research experience in pharma/CRO/consulting or academia; includes 3–4 years of late-phase clinical development.
- Highly preferred: Hematology/Oncology and/or Medical Oncology experience, especially solid tumors.
- Highly preferred: Experience leading clinical trials involving immune-based therapies and/or antibody drug conjugates.
- Prior experience leading clinical development/matrix teams across multiple regions; development experience beyond US/EU is a plus.
- Preferred: NDA/MAA/submission experience.
- Preferred: Demonstrated ability to lead/manage highly trained medical/scientific/technical professionals.
Skills
- Superior communication, strategic, interpersonal, and negotiating skills.
- Ability to proactively predict issues and solve problems.
- Ability to drive decision-making in multi-disciplinary, multi-regional matrix teams.
- Diplomacy and positive influencing across multinational cultures.
Knowledge
- Therapeutic area knowledge relevant to assigned compounds’ mechanisms of action.
- Regional/global regulatory requirements.
- GCP/ICH.
- Emerging research in the designated therapeutic area.
Travel Requirements
- Ability to travel ~15–25% (meetings/client sites; some international travel; overnight trips).
Compensation/Benefits
- U.S. Base Salary Range: $257,600.00–$404,800.00.
- May be eligible for incentives and certain benefits (medical/dental/vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time, and paid vacation).
Application Instructions
- Click the “Apply” button to begin the employment application process; information will be processed per Takeda’s Privacy Notice and Terms of Use.
Objectives
- Lead and drive strategy for global (US/EU/Japan) clinical development for multiple pipeline compounds, integrating medical, scientific, regulatory, and commercial issues.
- Lead multi-disciplinary, multi-regional matrix teams and create, maintain, and execute global clinical development plans to support regulatory approval in multiple regions.
- Set strategic direction influencing TGRD and TPC senior leadership decision-making.
Accountabilities
- Clinical Development team participation and leadership:
- Lead Global Development Team (US, EU, Japan) for assigned compounds; manage US/EU and Japan development teams (directly or via clinical scientist leadership).
- Direct development strategy and deliverables (Development Strategy, Clinical Development Plan, Clinical Protocols); recommend program scope/complexity impacting budgets.
- Monitor and interpret internal/external study data; make high-impact global “go/no go” and development plan/study design recommendations impacting timelines and labeling.
- Synopsis/Protocol development, study execution, and interpretation:
- Drive Clinical Science activities for synopses and protocols; advise clinical scientists; ensure successful completion of objectives with proactive contingency planning.
- Interpret data medically and scientifically, including relevance to individual patients.
- Trial Medical Monitoring:
- Oversee medical monitoring, assessing protocol conduct and subject safety; evaluate safety information with Pharmacovigilance.
- External interactions:
- Lead interactions with regulatory agencies and key opinion leaders; serve as advisor to clinical scientists and accountable to senior leadership for objectives.
- Due diligence, business development, and alliances:
- Identify/evaluate business development opportunities; conduct due diligence; develop and negotiate clinical development plans for alliances/in-licensing.
- Assess scientific/medical/development feasibility and strategic portfolio fit; represent clinical science on internal assessment teams.
- Serve as clinical contact for alliance projects; interface with partners and guide clinical scientists.
- Leadership/task force participation:
- Act as clinical science SME; represent clinical science on high-impact/priority task forces; lead internal and global cross-functional teams.
- Hire, manage, mentor, develop, and retain staff; conduct performance reviews, goal setting, and development planning.
Education/Experience/Qualifications
- MD (or internationally recognized equivalent) plus 7 years of clinical research experience in pharma/CRO/consulting or academia; includes 3–4 years of late-phase clinical development.
- Highly preferred: Hematology/Oncology and/or Medical Oncology experience, especially solid tumors.
- Highly preferred: Experience leading clinical trials involving immune-based therapies and/or antibody drug conjugates.
- Prior experience leading clinical development/matrix teams across multiple regions; development experience beyond US/EU is a plus.
- Preferred: NDA/MAA/submission experience.
- Preferred: Demonstrated ability to lead/manage highly trained medical/scientific/technical professionals.
Skills
- Superior communication, strategic, interpersonal, and negotiating skills.
- Ability to proactively predict issues and solve problems.
- Ability to drive decision-making in multi-disciplinary, multi-regional matrix teams.
- Diplomacy and positive influencing across multinational cultures.
Knowledge
- Therapeutic area knowledge relevant to assigned compounds’ mechanisms of action.
- Regional/global regulatory requirements.
- GCP/ICH.
- Emerging research in the designated therapeutic area.
Travel Requirements
- Ability to travel ~15–25% (meetings/client sites; some international travel; overnight trips).
Compensation/Benefits
- U.S. Base Salary Range: $257,600.00–$404,800.00.
- May be eligible for incentives and certain benefits (medical/dental/vision, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits, sick time, and paid vacation).
Application Instructions
- Click the “Apply” button to begin the employment application process; information will be processed per Takeda’s Privacy Notice and Terms of Use.