Director, Global Clinical Programs & Operations

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

Benefits offered by this job

Comprehensive medical

Dental

Vision

Prescription drug coverage

Company provided basic life

Accidental death & dismemberment

Short-term and long-term disability

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave programs

Other company provided benefits

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to oversee operational strategy for global clinical programs. You will coordinate with internal departments and ESPs to plan, execute, and complete programs in line with GCP/ICH and regulatory guidance within timelines and budget.

Responsibilities include leading program teams, developing CDP and regulatory submissions, and ensuring consistency of clinical dossiers across studies. Advanced degree preferred.

Qualifications

• Comprehensive knowledge of clinical operations, drug development process and GCP/ICH.
• Thorough knowledge of CROs, outsourcing, and vendor SOW evaluation.
• Advanced understanding of drug development principles and trial management.
• Strong knowledge of global regulatory requirements, biostatistics, data management and medical writing.

Responsibilities

• Provide scientific clinical research and operational expertise for GCDP strategy and objectives.
• Represent Clinical Management in development of CDP timelines and budgets.
• Ensure program standards (CRFs, outsourcing specs, templates) are applied across studies.
• Contribute to clinical trial reports, publications and presentations.
• Develop program level financial estimates and MLTP contributions.
• Lead program teams as Co-Chair or lead clinical management representative for meetings.

Skills

Clinical operations

GCP/ICH regulations

Regulatory compliance

Leadership

Budget planning

Cross-functional collaboration

Vendor management

Written and verbal communication

MS Office

eClinical systems (eCRFs/CTMS)

Education

Bachelor’s Degree in a pharmaceutical/science field

Advanced degree (preferred)

Tools

MS Office Suite

eClinical systems (eCRFs, CTMS)

Job description

Otsuka America Pharmaceutical Inc. seeks a Director of Clinical Management to oversee operational strategy for global clinical programs. You will coordinate with internal departments and ESPs to plan, execute, and complete programs in line with GCP/ICH and regulatory guidance within timelines and budget.

Responsibilities include leading program teams, developing CDP and regulatory submissions, and ensuring consistency of clinical dossiers across studies. Advanced degree preferred.