Director, Clinical Programs & Strategy

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

Benefits offered by this job

Comprehensive medical

Dental

Vision

Prescription drug coverage

Company provided life insurance

AD&D

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

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 oversee planning, execution, and completion of programs in line with ICH/GCP, SOPs, and budgets.

You will coordinate with ESPs, CROs, and internal partners, drive RD alignment, and ensure rigorous data integrity and reporting across studies. This role requires leadership, strong communication, and up to 25% travel.

Qualifications

• Comprehensive knowledge of clinical operations, drug development process, SOPs and GCP/ICH regulations.
• Thorough knowledge of CROs, outsourcing, and evaluation of vendor SOW.
• Advanced understanding of drug development principles and clinical trial implementation and management.
• Strong knowledge of global regulatory requirements and compliance, biostatistics, data management, and medical writing.
• Strong communication, organization, planning, analytical, problem solving, and people management skills.
• Strong computer skills with demonstrated experience in Word, Excel, PowerPoint, and Outlook; knowledge of eCRFs, IRT, CTMS.
• Ability to travel up to 25%.

Responsibilities

• Provides scientific clinical research and operational expertise in the development of the Global Clinical Development Plan (GCDP).
• Represents Clinical Management in development of the Clinical Development Plan, timelines, and budget for opportunities.
• Ensures program standards are applied across studies to ensure consistency of clinical dossier.
• Contributes to final analyses and development of clinical trial reports, publications, and presentations.
• Develops program level financial estimates and MLTP contributions.
• Leads program level teams as Co-Chair or lead clinical management representative for meetings (CRT/GBT/PDC/JDC/Alliance).
• Prepares and defends clinical program documents (IB/IMPD, IND/CTA reports, Health Authority submissions).
• Leads clinical sections of regulatory submissions and inspection readiness programs.

Skills

Clinical operations

GCP/ICH regulations

SOPs

Vendor management

Biostatistics

Data management

Medical writing

Communication

Leadership

Travel up to 25%

Education

Bachelor’s Degree with 14+ years pharma experience incl. 10 years trial management

Supervisory experience

Advanced Degree preferred

Job description

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to lead operational strategy for global clinical programs. You will oversee planning, execution, and completion of programs in line with ICH/GCP, SOPs, and budgets.

You will coordinate with ESPs, CROs, and internal partners, drive RD alignment, and ensure rigorous data integrity and reporting across studies. This role requires leadership, strong communication, and up to 25% travel.