Global Director, Clinical Management & Strategy

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

Benefits offered by this job

Comprehensive medical

Dental

Vision

Prescription drug coverage

401(k) match

Tuition reimbursement

Paid holidays

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to lead the operational strategy and management of clinical programs.

You will coordinate with internal teams, ESPs, and external partners to ensure timely execution within budget and in line with GCP/ICH and company SOPs. You will drive development of the Global Clinical Development Plan, oversee regulatory submissions, and guide trial design and publication strategy.

Qualifications

• Comprehensive knowledge of clinical operations, drug development and GCP/ICH regulations.
• Experience with CROs, outsourcing and vendor SOW evaluation.
• Advanced understanding of trial execution, regulatory submissions and health authority interactions.
• Strong communication, organization, planning, and people management skills.
• Proficiency with Microsoft Office and clinical trial software.

Responsibilities

• Oversee operational strategy and management of clinical programs within timelines and budget.
• Lead and coordinate cross-functional teams, ESP partnerships, and governance forums.
• Develop and defend clinical program documents and regulatory submissions.
• Drive HEOR strategy development and endpoint considerations.
• Ensure inspection readiness and data integrity across studies.

Skills

Clinical operations

Drug development

GCP/ICH compliance

Budgeting & forecasting

Leadership & supervision

Regulatory awareness

Cross-functional collaboration

Communication skills

Data interpretation & reporting

Travel up to 25%

Education

Bachelor’s Degree with 14+ years in pharma incl. 10+ years trials mgmt

Tools

CTMS

eCRFs

SOPs & regulatory docs

Job description

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to lead the operational strategy and management of clinical programs.

You will coordinate with internal teams, ESPs, and external partners to ensure timely execution within budget and in line with GCP/ICH and company SOPs. You will drive development of the Global Clinical Development Plan, oversee regulatory submissions, and guide trial design and publication strategy.