Director, Early-Phase Clinical Programs (Remote)

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

Benefits offered by this job

Comprehensive medical benefits

401(k) with match

Paid holidays and time off

Job summary

Otsuka America Pharmaceutical Inc. in the United States seeks a Director of Clinical Management to lead operational strategy and management of global clinical programs, in collaboration with senior leadership, ESPs, and external partners.

You will drive planning, execution, and submission of programs per ICH, GCP, and Otsuka SOPs, while managing timelines and budgets and mentoring program teams for high-quality clinical dossiers.

Qualifications

• Bachelor’s degree with extensive pharmaceutical industry experience and clinical trial management background.
• Previous supervisory experience and ability to lead program teams.
• Strong understanding of regulatory requirements and clinical development process.
• Proven ability to manage budgets, timelines, and CRO/vendor relationships.

Responsibilities

• Oversee operational strategy and management of global clinical programs.
• Coordinate with internal departments, ESPs, and external partners.
• Plan, execute, and close clinical programs per GCP/ICH and SOPs.
• Lead development of regulatory documents and trial reports.
• Manage program-level budgets and MLTP contributions.

Skills

Clinical operations knowledge

GCP & ICH regulations

Regulatory affairs understanding

Strategic planning

Budgeting & forecasting

People management

Vendor/SOW evaluation

Communication & cross-functional work

Microsoft Office proficiency

Travel up to 25%

Education

Bachelor’s Degree with 14 years in pharma incl. 10 years TM experience

Advanced Degree

Tools

eCRFs

IRT

CTMS

Job description

Otsuka America Pharmaceutical Inc. in the United States seeks a Director of Clinical Management to lead operational strategy and management of global clinical programs, in collaboration with senior leadership, ESPs, and external partners.

You will drive planning, execution, and submission of programs per ICH, GCP, and Otsuka SOPs, while managing timelines and budgets and mentoring program teams for high-quality clinical dossiers.