Remote Director of Clinical Management & Strategy

Otsuka America Pharmaceutical Inc.; Richmond (VA); Remote; USD 186,000 - 279,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision,

Generous 401(k) match and paid time

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical, Inc. in the United States is seeking a Director of Clinical Management to drive the operational strategy and oversight of clinical programs.

You will collaborate with the Senior Director and cross-functional teams to ensure programs meet regulations, timelines, and budget requirements. The role involves leading the Global Clinical Development Plan, coordinating with ESPs and external partners, and ensuring documentation, regulatory submissions, and trial data

Qualifications

• Comprehensive knowledge of clinical operations and GCP/ICH regulations.
• Experience assessing CROs, vendors, and SOWs.
• Strong understanding of global regulatory requirements in drug development.
• Proven leadership and people-management abilities.
• Tenacity in budget, timelines, and risk management.
• Willingness to travel up to 25%.

Responsibilities

• Oversee operational strategy and management of global clinical programs.
• Coordinate with internal departments and ESPs to execute programs on time and within budget.
• Lead development of Clinical Development Plans, timelines, and budgets.
• Prepare clinical program documents and regulatory submissions.
• Represent Clinical Management in meetings (CRT/GBT/PDC/JDC/Alliance).
• Ensure inspection readiness and data integrity across studies.

Skills

Clinical operations

GCP/ICH compliance

Vendor management

Regulatory affairs

Leadership

Communication skills

Data management

Travel ability

Education

Bachelor’s Degree in life sciences

Advanced degree preferred

Tools

Microsoft Office Suite

eCRFs/IRT/CTMS proficiency

GCP/ICH documentation tools

Job description

Otsuka America Pharmaceutical, Inc. in the United States is seeking a Director of Clinical Management to drive the operational strategy and oversight of clinical programs.

You will collaborate with the Senior Director and cross-functional teams to ensure programs meet regulations, timelines, and budget requirements. The role involves leading the Global Clinical Development Plan, coordinating with ESPs and external partners, and ensuring documentation, regulatory submissions, and trial data