Global Medical Director, Clinical Science

Regulatory Jobs; Cambridge (MA); Hybrid; USD 237,000 - 373,000; Full time

Job summary

Takeda in Cambridge, MA is seeking a Medical Director, Clinical Science to lead global clinical development strategy for GI2 TAU across US/EU/Japan, coordinating multi-regional teams and ensuring alignment with regulatory requirements.

This role drives protocol development, study execution, safety monitoring, and external interactions with regulators and key opinion leaders, with hybrid work and a competitive compensation package.

Qualifications

• MD or internationally recognized equivalent with clinical development experience.
• Experience leading multidisciplinary, multi-regional teams.
• NDA/MAA submissions experience preferred.
• Strong communication and strategic thinking.

Responsibilities

• Lead global development strategy and team across regions.
• Develop and approve synopses, protocols, and study designs.
• Oversee safety monitoring and pharmacovigilance alignment.
• Interact with regulators and key opinion leaders to influence development plans.
• Drive due diligence and alliance opportunities.

Skills

MD degree

Clinical development leadership

Regulatory strategy

Cross-functional leadership

Education

MD degree

Job description

Takeda in Cambridge, MA is seeking a Medical Director, Clinical Science to lead global clinical development strategy for GI2 TAU across US/EU/Japan, coordinating multi-regional teams and ensuring alignment with regulatory requirements.

This role drives protocol development, study execution, safety monitoring, and external interactions with regulators and key opinion leaders, with hybrid work and a competitive compensation package.