Senior Clinical Program Lead, Early-Phase Immunology

Otsuka America Pharmaceutical Inc.; Cheyenne (WY); On-site; USD 140,000 - 200,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. seeks a Sr. Manager, Clinical Management for early-phase immunology/autoimmune programs in the U.S. You will oversee planning, execution, and completion of clinical trials per ICH/GCP and internal SOPs, coordinating with CROs, ESPs, and cross-functional partners.

You will lead a clinical team, review critical study documents, manage budgets, and ensure compliance with timelines and milestones while maintaining data integrity and readiness for inspections.

Qualifications

• Ability to oversee complex First-in-Human SAD/MAD/POC trials in immunology/autoimmune indications.
• Thorough knowledge of CROs, outsourcing, and evaluating vendor SOWs.
• Strong understanding of clinical programs, and ability to translate to operational management.
• Strong understanding of global regulatory requirements.
• Strong communication, organization, planning, analytical and people management skills.

Responsibilities

• Oversee planning, execution, and completion of early-phase immunology/autoimmune trials in accordance with GCP and SOPs.
• Contribute to development/review of key study documents (protocols, ICFs, etc.).
• Identify/evaluate CROs, labs, IRBs, and investigative sites; manage ESPs and vendors.

Skills

First-in-Human Trials

CRO Oversight

Regulatory Knowledge

Team Leadership

Budget & Forecasting

Job description

Otsuka America Pharmaceutical Inc. seeks a Sr. Manager, Clinical Management for early-phase immunology/autoimmune programs in the U.S. You will oversee planning, execution, and completion of clinical trials per ICH/GCP and internal SOPs, coordinating with CROs, ESPs, and cross-functional partners.

You will lead a clinical team, review critical study documents, manage budgets, and ensure compliance with timelines and milestones while maintaining data integrity and readiness for inspections.