Director, Clinical Program Strategy

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

Benefits offered by this job

Comprehensive medical

Dental

Vision

Prescriptions drug coverage

401(k) match

Flexible time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Director who will collaboratively manage clinical programs, overseeing operational strategy, timelines, and budgets in alignment with GCP/ICH guidelines and Otsuka SOPs.

The role involves coordinating with internal departments and external service providers to ensure high-quality clinical development and regulatory submissions. The position requires extensive clinical operations expertise, supervision experience, and strong communication to drive

Qualifications

• Comprehensive knowledge of clinical operations, drug development process and GCP/ICH regulations.
• Strong understanding of CROs, outsourcing, and vendor evaluation.
• Experience in clinical trial management and supervisory roles.
• Excellent communication, planning, and leadership skills.

Responsibilities

• Provide scientific and operational leadership for the Global Clinical Development Plan.
• Oversee program level budgeting, timelines, and resource planning.
• Ensure standardization across studies (CRFs, templates, training).
• Lead development of regulatory documents and HEOR strategies.
• Represent Clinical Management in cross-functional initiatives and ESP governance.

Education

Bachelor’s Degree

Advanced Degree

Job description

Otsuka America Pharmaceutical Inc. is seeking a Director who will collaboratively manage clinical programs, overseeing operational strategy, timelines, and budgets in alignment with GCP/ICH guidelines and Otsuka SOPs.

The role involves coordinating with internal departments and external service providers to ensure high-quality clinical development and regulatory submissions. The position requires extensive clinical operations expertise, supervision experience, and strong communication to drive