Clinical Science Lead, Medical Director - GI2

Regulatory Jobs; Cambridge (MA); Hybrid; USD 199,000 - 312,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Takeda is seeking an Associate Medical Director, Clinical Science, GI2 TAU in Cambridge, MA. You will lead clinical science activities on projects, shape development plans, and interface with global teams and external stakeholders to support regulatory submissions.

The role emphasizes leadership, cross-functional collaboration, and ensuring trials meet global regulatory requirements, with hybrid work and a focus on innovative, patient-centered outcomes.

Qualifications

• MD or internationally recognized equivalent plus 3 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination).
• Subspecialty in Immunology preferred.
• Phase 3 Clinical Trial experience preferred.
• Previous experience leading matrix teams preferred.
• Management experience preferred.

Responsibilities

• Represents Clinical Science on Project or Clinical Teams and may serve as the Clinical Science leader on these teams.
• Supports the Global Project Team to ensure clinical activities align with the global strategy.
• Contributes to the Clinical Development Plan, leads protocol development and documents for CDP and study execution and regulatory submissions.
• Monitors data from ongoing studies and makes recommendations impacting timelines or labeling.
• Directs interactions with key opinion leaders and leads strategic meetings and negotiations.
• Interacts with external partners to align on Takeda's strategic goals.

Skills

Superior communication

Strategic thinking

Interpersonal skills

Negotiation skills

Education

MD or international equivalent + 3 years clinical research experience

Job description

Takeda is seeking an Associate Medical Director, Clinical Science, GI2 TAU in Cambridge, MA. You will lead clinical science activities on projects, shape development plans, and interface with global teams and external stakeholders to support regulatory submissions.

The role emphasizes leadership, cross-functional collaboration, and ensuring trials meet global regulatory requirements, with hybrid work and a focus on innovative, patient-centered outcomes.