Remote Director, Clinical Management & Strategy

Otsuka America Pharmaceutical Inc.; Boise (ID); Remote; USD 186,000 - 279,000; Full time

Benefits offered by this job

Medical benefits

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Director of Clinical Management to lead operational strategy for global clinical programs. You will coordinate across departments and ESPs, ensuring adherence to ICH/GCP guidelines, timelines, and budgets.

You will drive development of clinical development plans, manage budgets, and contribute to regulatory submissions while mentoring the team and ensuring inspection readiness across programs.

Qualifications

• Comprehensive knowledge of clinical operations and drug development processes.
• Strong understanding of global regulatory requirements and compliance.
• Experience coordinating CROs, ESPs, and vendor management.

Responsibilities

• Oversee operational strategy and management of clinical programs.
• Coordinate with internal departments and external service providers.
• Lead program teams as Co-Chair for cross-functional meetings.
• Prepare regulatory documents and health authority submissions.
• Develop program budgets, timelines, and risk mitigations.

Skills

Clinical operations

GCP/ICH regulations

Biostatistics

Data management

Education

Bachelor’s Degree in life sciences

Tools

CTMS

eCRF

MS Office

Job description

Otsuka America Pharmaceutical Inc. is seeking a Director of Clinical Management to lead operational strategy for global clinical programs. You will coordinate across departments and ESPs, ensuring adherence to ICH/GCP guidelines, timelines, and budgets.

You will drive development of clinical development plans, manage budgets, and contribute to regulatory submissions while mentoring the team and ensuring inspection readiness across programs.