Senior Clinical Program Lead - Early-Phase Immunology

Otsuka America Pharmaceutical Inc.; San Juan (PR); Remote; USD 150,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Sr. Manager, Clinical Management to oversee early-phase immunology/autoimmune studies, ensuring adherence to ICH/GCP and company SOPs. You will coordinate with CROs, ESPs, and investigative sites while guiding a clinical team to meet timelines and budgets.

The role emphasizes leadership, risk management, and TMF readiness, with travel up to 25% and a focus on program-level improvements and compliance across portfolios.

Qualifications

• Bachelor’s Degree or RN with 10+ years industry experience and 7+ years in clinical trial management.

Responsibilities

• Provide oversight and management of early-phase clinical trials in immunology/autoimmune indications according to ICH/GCP and SOPs.
• Lead development and review of critical study documents (protocols, ICFs, etc.).
• Evaluate and select CROs and external vendors; oversee ESPs and investigative sites.
• Guide clinical team to ensure compliance with regulations, budgets, and timelines.
• Forecast study expenditures and resourcing; monitor budget and variance communications.
• Ensure TMF completeness and readiness for inspections; support risk mitigation at program level.
• Represent Clinical Management in cross-functional initiatives and drive standardization and improvements.
• Supervise training and onboarding of staff; set performance expectations and provide feedback.

Skills

Clinical trial management

Budget management

Vendor management

GCP/ICH knowledge

Cross-functional leadership

Communication

Education

Bachelor’s Degree or RN

Tools

eCRFs

IRT

CTMS

Job description

Otsuka America Pharmaceutical Inc. is seeking a Sr. Manager, Clinical Management to oversee early-phase immunology/autoimmune studies, ensuring adherence to ICH/GCP and company SOPs. You will coordinate with CROs, ESPs, and investigative sites while guiding a clinical team to meet timelines and budgets.

The role emphasizes leadership, risk management, and TMF readiness, with travel up to 25% and a focus on program-level improvements and compliance across portfolios.