Director, Clinical Management (Early-Phase Immunology)

Otsuka Pharmaceutical Co., Ltd.; United States; On-site; USD 186,000 - 279,000; Full time

Benefits offered by this job

Comprehensive medical coverage

Dental coverage

Vision coverage

401(k) match

Tuition reimbursement

Paid holidays

Job summary

Otsuka Pharmaceutical Co., Ltd. in the United States is seeking a Director to oversee operational strategy and management of global clinical programs, coordinating with the Senior Director of Clinical Management and external service providers to ensure timely, compliant delivery within budget.

You will lead program-level activities, develop development plans, oversee budgets, and coordinate cross-functional teams across regulatory, medical writing, and data management.

Qualifications

• Comprehensive knowledge of clinical operations and GCP/ICH regulations.
• Experience with CROs, outsourcing and vendor SOW evaluation.
• Advanced drug development understanding and trial management.
• Strong regulatory and data management knowledge.
• Excellent communication, planning and leadership skills.

Responsibilities

• Provide scientific clinical research and operational expertise for GCDP strategy.
• Represent Clinical Management in development of budgets and timelines.
• Ensure program standards are applied across studies for dossier consistency.
• Contribute to clinical trial reports, publications and presentations.
• Lead program-level teams and participate in governance meetings.
• Develop HEOR strategy and endpoint development as needed.
• Partner with medical affairs and external service providers for information needs.
• Oversee regulatory document development and inspections readiness.

Skills

Clinical operations

GCP/ICH compliance

Regulatory knowledge

Budgeting

Team leadership

Cross-functional coordination

Travel up to 25%

Education

Bachelor's Degree in Life Sciences

Advanced Degree

Tools

eCRFs

IRT

CTMS

Job description

Otsuka Pharmaceutical Co., Ltd. in the United States is seeking a Director to oversee operational strategy and management of global clinical programs, coordinating with the Senior Director of Clinical Management and external service providers to ensure timely, compliant delivery within budget.

You will lead program-level activities, develop development plans, oversee budgets, and coordinate cross-functional teams across regulatory, medical writing, and data management.