Director, Early-Phase Clinical Management

Otsuka Pharmaceutical Co., Ltd; Northern (KY); Hybrid; USD 186,000 - 279,000; Full time

Benefits offered by this job

Comprehensive medical

Dental insurance

Vision care

401(k) match

Tuition reimbursement

Job summary

Otsuka Pharmaceutical Co., Ltd seeks a Director of Clinical Management to oversee operational strategy for global clinical programs. You will coordinate with internal departments and external ESPs to execute clinical programs within timelines and budgets, ensuring compliance with GCP/ICH and SOPs.

Responsibilities include planning, execution, and management across multiple studies, with leadership of program teams.

Qualifications

• Comprehensive knowledge of clinical operations and GCP/ICH regulations.
• Thorough knowledge of CROs, outsourcing, and vendor SOW evaluation.
• Advanced understanding of drug development 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, training, templates) are consistently applied across studies.
• Lead program-level teams as Co-Chair or lead clinical management representative.
• Contribute to regulatory documents and health authority submissions.
• Develop HEOR strategy and endpoint development where necessary.
• Support medical information and publications strategies; liaise with internal/external stakeholders.

Skills

Clinical operations

GCP/ICH knowledge

Regulatory knowledge

Leadership/people management

Data management

Communication & planning

Education

Advanced degree

Tools

eCRFs

IRT

CTMS

Job description

Otsuka Pharmaceutical Co., Ltd seeks a Director of Clinical Management to oversee operational strategy for global clinical programs. You will coordinate with internal departments and external ESPs to execute clinical programs within timelines and budgets, ensuring compliance with GCP/ICH and SOPs.

Responsibilities include planning, execution, and management across multiple studies, with leadership of program teams.