Director, Global Clinical Programs & Operations

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

Benefits offered by this job

Comprehensive medical

Dental

Vision

401(k) match

Paid holidays

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to oversee operational strategy and management of clinical programs. You will coordinate with internal teams and ESPs to plan, execute, and complete programs in line with GCP and ICH guidelines, within timelines and budgets.

You will lead program-level teams, contribute to regulatory submissions, and shape HEOR strategy with key advisors. Strong leadership, communication, and cross-functional collaboration are essential.

Qualifications

• Comprehensive knowledge of clinical operations and GCP/ICH regulations.
• Experience in CRO management, outsourcing, and SOW evaluation.
• Strong leadership and program management capabilities.

Responsibilities

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

Skills

Clinical ops

GCP/ICH

Leadership

Strategic planning

Budgeting

Data analysis

Biostatistics

Vendor management

Communication

Education

Bachelor’s Degree with 14 years pharma experience

Advanced Degree

Tools

eCRFs

CTMS

Microsoft Office

Job description

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to oversee operational strategy and management of clinical programs. You will coordinate with internal teams and ESPs to plan, execute, and complete programs in line with GCP and ICH guidelines, within timelines and budgets.

You will lead program-level teams, contribute to regulatory submissions, and shape HEOR strategy with key advisors. Strong leadership, communication, and cross-functional collaboration are essential.