Senior Clinical Program Lead: Early-Phase Immunology

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

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Manager of Clinical Management to oversee early phase immunology/autoimmune studies (P1-2a).

You will coordinate with internal teams and external partners to plan, execute, and complete trials in compliance with ICH GCP and Otsuka SOPs. The role requires leadership to guide clinical staff, manage vendor relationships, and ensure budgets and timelines are met across portfolios.

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 and its operational translation.
• Strong understanding of global regulatory requirements.
• Strong communication, organization, planning, analytical and leadership skills.

Responsibilities

• Provide oversight and management of Otsuka early phase clinical studies (P1-2a).
• Coordinate development and review of critical study documents (protocols, ICFs, etc.).
• Assess and select CROs and ESPs and manage external vendors and sites.
• Lead and guide clinical team to ensure compliance with ICH GCP and SOPs.
• Communicate study progress, budget, and resource needs across cross-functional groups.
• Support forecasting of expenditures and resourcing; monitor budget variances.

Skills

SAD/MAD/POC Trials

CRO Oversight

Regulatory Knowledge

People Management

Operational Management

Job description

Otsuka America Pharmaceutical Inc. is seeking a Senior Manager of Clinical Management to oversee early phase immunology/autoimmune studies (P1-2a).

You will coordinate with internal teams and external partners to plan, execute, and complete trials in compliance with ICH GCP and Otsuka SOPs. The role requires leadership to guide clinical staff, manage vendor relationships, and ensure budgets and timelines are met across portfolios.