Medical Director, Clinical Science - Solid Tumor
Takeda
10 hours ago
Remote friendly (Boston, MA)
United States
$237,200 - $372,790 USD yearly
Clinical Research and Development
Medical Director, Clinical Science, Solid Tumor (Global clinical development: US/EU/Japan)
Responsibilities
- Lead and drive strategy for global clinical development for assigned Takeda pipeline compounds; integrate medical, scientific, regulatory, and commercial considerations; execute global clinical development plan to support regulatory approval.
- Lead multi-disciplinary, multi-regional matrix teams through complex decisions; set strategic direction influencing TGRD/TPC senior leadership.
- Establish and drive development strategy, clinical development plan, and clinical protocols; manage scope/complexity and influence program budget.
- Monitor and interpret internal/external study data; make high-impact recommendations (e.g., go/no-go; plan/study design modifications).
- Drive synopses/protocol development and clinical study design, execution oversight, and interpretation; present conclusions and impact on compound strategy.
- Lead trial medical monitoring: assess protocol conduct, subject safety, and overall safety with Pharmacovigilance; make final decisions on study conduct regarding scientific integrity.
- Lead regulatory interactions and KOL relationship activities; direct preparation of regulatory-facing documents and responses.
- Lead/participate in due diligence, business development, and alliance/in-licensing clinical development plans; serve as clinical contact for alliance projects.
- Hire, manage, mentor, and develop staff; conduct performance reviews and goal setting.
Qualifications (Required/Preferred)
- MD or combined MD/PhD (or equivalent) + 5 years clinical research experience (pharma/CRO/consulting/academia).
- Preferred: Hematology/Oncology and/or Medical Oncology (solid tumors), immune-based therapies and/or antibody-drug conjugates, late-phase development and NDA/MAA submission, prior matrix/team leadership across regions.
Skills/Knowledge
- Strong communication/influencing; problem-solving; decision-making in multi-disciplinary, multi-regional matrix teams.
- Therapeutic area/mechanism-of-action knowledge; regulatory requirements; GCP/ICH; emerging research.
Travel
- ~15–25% (including occasional international).
Benefits (explicitly stated)
- Eligible for medical/dental/vision, 401(k) + match, disability and 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.
Location
- Boston, MA
Responsibilities
- Lead and drive strategy for global clinical development for assigned Takeda pipeline compounds; integrate medical, scientific, regulatory, and commercial considerations; execute global clinical development plan to support regulatory approval.
- Lead multi-disciplinary, multi-regional matrix teams through complex decisions; set strategic direction influencing TGRD/TPC senior leadership.
- Establish and drive development strategy, clinical development plan, and clinical protocols; manage scope/complexity and influence program budget.
- Monitor and interpret internal/external study data; make high-impact recommendations (e.g., go/no-go; plan/study design modifications).
- Drive synopses/protocol development and clinical study design, execution oversight, and interpretation; present conclusions and impact on compound strategy.
- Lead trial medical monitoring: assess protocol conduct, subject safety, and overall safety with Pharmacovigilance; make final decisions on study conduct regarding scientific integrity.
- Lead regulatory interactions and KOL relationship activities; direct preparation of regulatory-facing documents and responses.
- Lead/participate in due diligence, business development, and alliance/in-licensing clinical development plans; serve as clinical contact for alliance projects.
- Hire, manage, mentor, and develop staff; conduct performance reviews and goal setting.
Qualifications (Required/Preferred)
- MD or combined MD/PhD (or equivalent) + 5 years clinical research experience (pharma/CRO/consulting/academia).
- Preferred: Hematology/Oncology and/or Medical Oncology (solid tumors), immune-based therapies and/or antibody-drug conjugates, late-phase development and NDA/MAA submission, prior matrix/team leadership across regions.
Skills/Knowledge
- Strong communication/influencing; problem-solving; decision-making in multi-disciplinary, multi-regional matrix teams.
- Therapeutic area/mechanism-of-action knowledge; regulatory requirements; GCP/ICH; emerging research.
Travel
- ~15–25% (including occasional international).
Benefits (explicitly stated)
- Eligible for medical/dental/vision, 401(k) + match, disability and 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.
Location
- Boston, MA