Senior Clinical Program Lead, Early-Phase Immunology

Otsuka America Pharmaceutical Inc.; Honolulu (HI); On-site; USD 140,000 - 190,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Sr. Manager in Clinical Management for Early Phase immunology/autoimmune programs. You will oversee planning, execution and completion of P1-2a studies, coordinating with internal departments, ESPs and CROs to ensure quality, regulatory compliance and on-time delivery.

You will lead a clinical team, contribute to protocol development, budgeting and risk mitigation, and support TMF readiness and cross-functional initiatives across portfolios.

Qualifications

• Ability to oversee complex First in Human SAD/MAD/POC trials in immunology/autoimmune indications.
• Thorough knowledge of CROs and vendor SOW evaluation.
• Strong understanding of global regulatory requirements.
• Excellent communication, organization, planning, analytical, problem-solving and people management skills.

Responsibilities

• Oversee planning, execution and completion of early-phase clinical trials per ICH/GCP and SOPs.
• Develop and review critical clinical documents (protocols, informed consent forms).
• Identify, evaluate, and select CROs, ESPs, and investigative sites.
• Lead clinical team to ensure compliance and timely study activities across cross-functional teams.
• Forecast study expenditures and resource needs; monitor budget variances and report to directors.
• Ensure TMF completeness and inspection readiness for assigned trials.
• Represent Clinical Management in protocol reviews and cross-portfolio initiatives.

Skills

Trial oversight

Vendor management

Regulatory knowledge

Communication & leadership

Program budgeting

Job description

Otsuka America Pharmaceutical Inc. is seeking a Sr. Manager in Clinical Management for Early Phase immunology/autoimmune programs. You will oversee planning, execution and completion of P1-2a studies, coordinating with internal departments, ESPs and CROs to ensure quality, regulatory compliance and on-time delivery.

You will lead a clinical team, contribute to protocol development, budgeting and risk mitigation, and support TMF readiness and cross-functional initiatives across portfolios.