Remote Director of Clinical Programs & Strategy

Otsuka America Pharmaceutical Inc.; San Juan (PR); Remote; USD 186,000 - 279,000; Full time

Benefits offered by this job

Comprehensive medical

Dental

Vision

401(k) match

Tuition reimbursement

Paid holidays

Paid leave programs

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to lead operational strategy for global clinical programs.

You will collaborate with Senior Directors, coordinate with ESPs and internal teams, and drive planning, execution, and timely completion within regulatory and budgetary constraints. The role requires deep expertise in GCP/ICH, trial management, CRO oversight, and cross-functional leadership.

Qualifications

• Comprehensive knowledge of clinical operations and GCP/ICH regulations.
• Experience with CROs, outsourcing and vendor SOW evaluation.
• Strong drug development principles and trial management experience.
• Knowledge of global regulatory requirements, biostatistics, data management and medical writing.
• Ability to travel up to 25%.

Responsibilities

• Provide clinical research and operational expertise within the GCDP strategy.
• Develop and oversee timelines and budgets for clinical programs.
• Ensure standards (CRFs, templates, etc.) are applied across studies.
• Lead program-level teams as Co-Chair or lead clinical management rep.
• Contribute to HEOR strategy and endpoints where needed.

Skills

Clinical operations

GCP/ICH knowledge

Regulatory compliance

Project management

Data management

Communication

Vendor management

Education

Bachelor’s Degree + 14 years pharma experience

Advanced degree

Tools

Microsoft Office

eCRFs

CTMS

IRT

Job description

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to lead operational strategy for global clinical programs.

You will collaborate with Senior Directors, coordinate with ESPs and internal teams, and drive planning, execution, and timely completion within regulatory and budgetary constraints. The role requires deep expertise in GCP/ICH, trial management, CRO oversight, and cross-functional leadership.