Medical Director, Clinical Science – Development Leader

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

Job summary

Takeda in Cambridge, MA seeks a Medical Director, Clinical Science (GI2 TAU) to lead global development strategy across US/EU/Japan. You will guide multi-regional teams, shape clinical programs, and interact with regulatory and scientific leaders to advance programs toward regulatory approval.

The role requires MD or equivalent and 5+ years in clinical research with experience managing cross-functional teams, NDA/MAA submissions, and strategic decision-making in a matrix organization.

Qualifications

• MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia.
• Previous experience leading a clinical development team with responsibility for studies in multiple regions.
• NDA/MAA/Submission experience preferred.
• Management experience

Responsibilities

• Leads Global (US/EU/Japan) Development Team and represents Clinical Science on the Global Development Team.
• Develops Development Strategy, Clinical Development Plan and Clinical Protocols; manages budget and contingency planning.
• Oversees data interpretation and go/no-go decisions impacting timelines and labeling.
• Drives synopses, protocols and conduct of clinical studies; presents study conclusions to Management.
• Directs medical monitoring activities and safety assessments in collaboration with Pharmacovigilance.
• Leads interactions with regulatory authorities and key opinion leaders to shape development plans.
• Identifies and evaluates potential alliances and due diligence opportunities in clinical development.

Skills

Superior communication

Strategic thinking

Interpersonal skills

Negotiation skills

Problem solving

Diplomacy

Education

MD or international equivalent

Job description

Takeda in Cambridge, MA seeks a Medical Director, Clinical Science (GI2 TAU) to lead global development strategy across US/EU/Japan. You will guide multi-regional teams, shape clinical programs, and interact with regulatory and scientific leaders to advance programs toward regulatory approval.

The role requires MD or equivalent and 5+ years in clinical research with experience managing cross-functional teams, NDA/MAA submissions, and strategic decision-making in a matrix organization.