Senior Clinical Program Lead, Early-Phase Immunology

Otsuka Pharmaceutical Co., Ltd; Northern (KY); Hybrid; USD 150,000 - 224,000; Full time

Job summary

Otsuka Pharmaceutical Co., Ltd seeks a Sr. Manager, Clinical Management for early-phase immunology/autoimmune programs. You will oversee planning, execution, and completion of trials, aligning with ICH GCP and Otsuka SOPs, while leading cross-functional teams and external partners to ensure quality and timely delivery.

You will intake study documents, manage budgets, and participate in risk mitigation and TMF readiness. Travel up to 25% and senior-level leadership experience are expected.

Qualifications

• Oversee complex First in Human SAD/MAD/POC trials in immunology/autoimmune indications.
• Strong understanding of global regulatory requirements and GCP/ICH.
• Experience with CROs, outsourcing, and SOW evaluation.

Responsibilities

• Provide oversight of clinical studies from planning through completion within timelines and budgets.
• Lead cross-functional teams and coordinate with ESPs, CROs, central labs, and sites.
• Develop and review critical study documents (protocols, informed consent, etc.).
• Forecast expenditures and manage study budgets; report variances to leadership.
• Ensure TMF completeness, quality, and inspection readiness.
• Represent Clinical Management in cross-functional initiatives and standardization efforts.

Skills

Clinical trial management

Immunology autoimmune trials

SAD/MAD/POC studies

GCP/ICH compliance

Vendor management

Budget forecasting

Team leadership

Regulatory knowledge

Travel up to 25%

Education

Bachelor's Degree or RN

Tools

MS Office (Word/Excel/PowerPoint/Outlook)

eCRFs

IRT

CTMS

Job description

Otsuka Pharmaceutical Co., Ltd seeks a Sr. Manager, Clinical Management for early-phase immunology/autoimmune programs. You will oversee planning, execution, and completion of trials, aligning with ICH GCP and Otsuka SOPs, while leading cross-functional teams and external partners to ensure quality and timely delivery.

You will intake study documents, manage budgets, and participate in risk mitigation and TMF readiness. Travel up to 25% and senior-level leadership experience are expected.