Senior Clinical Program Manager - Early Phase Immunology

Otsuka Pharmaceutical Co., Ltd; United States; Remote; USD 150,000 - 224,000; Full time

Job summary

Otsuka Pharmaceutical Co., Ltd is seeking a Sr. Manager, Clinical Management for Early Phase immunology/auto-immune studies in the United States.

You will oversee planning, execution and completion of P1-2a trials, coordinating with departments, ESPs and CROs to ensure GCP-compliant delivery within timelines and budget. The role demands ten years of industry experience, with seven in clinical trial management, strong leadership, and risk mitigation.

Qualifications

• Bachelor’s Degree or RN with 10+ years in the industry, seven in clinical trial management.
• Experience overseeing First-in-Human SAD/MAD/POC immunology/autoimmune studies.
• Strong understanding of global regulatory requirements and GCP/ICH.

Responsibilities

• Oversee planning, execution, and completion of early phase trials per GCP/ICH.
• Develop and review critical study documents (protocols, ICFs, etc.).
• Identify and evaluate CROs and ESPs; manage cross-functional coordination.
• Lead clinical team and monitor budget, scope and resource needs.
• Ensure TMF completeness, data integrity and inspection readiness.

Skills

Complex trial oversight

CRO/vendor management

Regulatory compliance

Leadership and people mgmt

Budget & forecasting

TMF and data integrity

Microsoft Office/CTMS tools

Education

Bachelor’s Degree or RN

Tools

eCRFs

IRT

CTMS

MS Office

Job description

Otsuka Pharmaceutical Co., Ltd is seeking a Sr. Manager, Clinical Management for Early Phase immunology/auto-immune studies in the United States.

You will oversee planning, execution and completion of P1-2a trials, coordinating with departments, ESPs and CROs to ensure GCP-compliant delivery within timelines and budget. The role demands ten years of industry experience, with seven in clinical trial management, strong leadership, and risk mitigation.