Medical Director, Clinical Science, GI2 TAU
Takeda
August 22, 2026
Remote friendly (Cambridge, MA)
United States
$237,200 - $372,790 USD yearly
Clinical Research and Development
ACCOUNTABILITIES
- Represents Clinical Science on project/clinical teams; may serve as Clinical Science leader.
- Ensures clinical team activities align with global strategy.
- Supports Asset Strategy: develops Clinical Development Plan (CDP), leads Clinical Protocols and documents for CDP/study execution and regulatory submissions; recommends scope/complexity/size and influences study budget.
- Maintains state-of-the-art development strategy aligned with regulatory requirements; identifies challenges and develops contingency plans.
- Monitors/interprets high-impact global decisions from internal/external studies; makes recommendations affecting go/no-go decisions, development plan/study design, timelines, and labeling.
Synopsis/Protocol Development, Study Execution, & Interpretation
- Leads preparation/approval of synopses and protocols; advises clinical scientists; accountable for study design and interpretation.
- Presents conclusions to management; determines impact on compound strategy.
- Interprets data scientifically and in medical context for patients.
Trial Medical Monitoring
- Medical monitoring of protocol conduct and subject safety; assesses safety with Pharmacovigilance.
- Oversees non-medical clinical scientists on assessments.
- Makes final decisions on scientific integrity of study conduct.
External Interactions & BD/Alliances
- Leads KOL and regulatory authority interactions; supports strategy, briefing reports, and formal responses.
- Performs due diligence and develops/negotiates clinical development plans for alliances/in-licensing; clinical point of contact for alliance projects.
EDUCATION/EXPERIENCE (Required/Preferred)
- MD (or equivalent) + 5 years clinical research experience (pharma/CRO/academia); Hepatology or Immunology highly preferred; alpha-1 antitrypsin deficiency a plus.
- Phase 3 clinical trial experience preferred; leading clinical development/matrix teams in multiple regions.
- NDA/MAA/submission and launch experience preferred; management experience preferred.
SKILLS/KNOWLEDGE
- Communication, strategic, interpersonal, negotiation; proactive problem-solving; decision-making in matrix teams; diplomacy/influence.
- Therapeutic area/mechanism knowledge; regulatory requirements; GCP/ICH; emerging research.
TRAVEL
- ~15–25% travel; overnight and some international as needed.
BENEFITS (as stated)
- 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/year; up to 120 hours paid vacation for new hires.
- Represents Clinical Science on project/clinical teams; may serve as Clinical Science leader.
- Ensures clinical team activities align with global strategy.
- Supports Asset Strategy: develops Clinical Development Plan (CDP), leads Clinical Protocols and documents for CDP/study execution and regulatory submissions; recommends scope/complexity/size and influences study budget.
- Maintains state-of-the-art development strategy aligned with regulatory requirements; identifies challenges and develops contingency plans.
- Monitors/interprets high-impact global decisions from internal/external studies; makes recommendations affecting go/no-go decisions, development plan/study design, timelines, and labeling.
Synopsis/Protocol Development, Study Execution, & Interpretation
- Leads preparation/approval of synopses and protocols; advises clinical scientists; accountable for study design and interpretation.
- Presents conclusions to management; determines impact on compound strategy.
- Interprets data scientifically and in medical context for patients.
Trial Medical Monitoring
- Medical monitoring of protocol conduct and subject safety; assesses safety with Pharmacovigilance.
- Oversees non-medical clinical scientists on assessments.
- Makes final decisions on scientific integrity of study conduct.
External Interactions & BD/Alliances
- Leads KOL and regulatory authority interactions; supports strategy, briefing reports, and formal responses.
- Performs due diligence and develops/negotiates clinical development plans for alliances/in-licensing; clinical point of contact for alliance projects.
EDUCATION/EXPERIENCE (Required/Preferred)
- MD (or equivalent) + 5 years clinical research experience (pharma/CRO/academia); Hepatology or Immunology highly preferred; alpha-1 antitrypsin deficiency a plus.
- Phase 3 clinical trial experience preferred; leading clinical development/matrix teams in multiple regions.
- NDA/MAA/submission and launch experience preferred; management experience preferred.
SKILLS/KNOWLEDGE
- Communication, strategic, interpersonal, negotiation; proactive problem-solving; decision-making in matrix teams; diplomacy/influence.
- Therapeutic area/mechanism knowledge; regulatory requirements; GCP/ICH; emerging research.
TRAVEL
- ~15–25% travel; overnight and some international as needed.
BENEFITS (as stated)
- 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/year; up to 120 hours paid vacation for new hires.