Senior Clinical Study Manager, Early-Phase Immunology

Otsuka America Pharmaceutical Inc.; Boise (ID); On-site; USD 180,000 - 230,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Sr. Manager, Clinical Management to oversee early-phase immunology/autoimmune trials (P1-2a). You will coordinate with internal teams, ESPs, CROs, and sites to plan, execute, and close studies in compliance with GCP and SOPs, while managing budgets and timelines.

The role requires leadership of a clinical team, strategic input into study documents, and ongoing risk and budget management to ensure quality and compliance across programs.

Qualifications

• Ability to oversee complex first-in-human SAD/MAD/POC trials in immunology/autoimmune indications.
• Thorough knowledge of CROs, outsourcing, and evaluation of vendor SOWs.
• Strong understanding of clinical and scientific basis for assigned program with operational translation.
• Strong understanding of global regulatory requirements.
• Strong communication, organization, planning, analytical, problem solving, and people management skills.

Responsibilities

• Provide oversight and management of clinical studies per regulations, ICH/GCP, and SOPs.
• Contribute to development/review of critical clinical study documents (protocols, consent forms, etc.).
• Identify, evaluate, and select CROs, ESPs, and investigative sites.
• Lead clinical team to ensure activities meet regulations and SOPs; provide updates on scope, schedule, resources.
• Coordinate cross-functional communication on project activities and progress.

Skills

Clinical trial management

Vendor management

Regulatory knowledge

Communication & leadership

Job description

Otsuka America Pharmaceutical Inc. is seeking a Sr. Manager, Clinical Management to oversee early-phase immunology/autoimmune trials (P1-2a). You will coordinate with internal teams, ESPs, CROs, and sites to plan, execute, and close studies in compliance with GCP and SOPs, while managing budgets and timelines.

The role requires leadership of a clinical team, strategic input into study documents, and ongoing risk and budget management to ensure quality and compliance across programs.