Director of Clinical Programs & Operations

Otsuka America Pharmaceutical Inc.; Helena (MT); On-site; USD 186,000 - 279,000; Full time

Benefits offered by this job

Comprehensive medical

Dental

Vision

401(k) match

Paid holidays

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to lead the operational strategy for global clinical programs and coordinate with internal teams and ESPs to plan, execute, and complete programs within timelines and budget.

The role develops development plans, oversees budgets, and supports regulatory submissions, ensuring data integrity and strong cross-functional collaboration. Travel up to 25% may be required.

Qualifications

• Comprehensive knowledge of clinical operations, drug development and GCP/ICH regulations.
• Thorough knowledge of CROs, outsourcing and vendor SOW evaluation.
• Advanced understanding of drug development principles and trial management.

Responsibilities

• Provide scientific clinical research and operational expertise for the Global Clinical Development Plan.
• Represent Clinical Management in development of timelines and budgets for opportunities.
• Ensure program standards (CRFs, outsourcing specs, training) are applied across studies.

Skills

Clinical operations

GCP/ICH compliance

Regulatory awareness

Vendor management

Leadership

Education

Bachelor's degree in life sciences

Tools

Microsoft Office

eCRFs

CTMS

IRT

Job description

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to lead the operational strategy for global clinical programs and coordinate with internal teams and ESPs to plan, execute, and complete programs within timelines and budget.

The role develops development plans, oversees budgets, and supports regulatory submissions, ensuring data integrity and strong cross-functional collaboration. Travel up to 25% may be required.