Global Clinical Development Director — Remote

Otsuka America Pharmaceutical Inc.; Columbus (OH); Remote; USD 210,000 - 313,000; Full time

Benefits offered by this job

Comprehensive benefits

401(k) match

Paid holidays and leave

Job summary

Otsuka America Pharmaceutical Inc. seeks a Director, Global Clinical Development to design and oversee clinical research programs for OPDC products, with options to work remotely or in Princeton, NJ or Rockville, MD.

The role focuses on Rheumatology, Immunology and Specialty Medicine, collaborating with regulatory agencies and internal teams. You will lead trial strategies, sign NDA/safety documents, mentor staff, manage CRO/vendor relationships, and support regulatory filings while maintaining

Qualifications

• Clinician with rheumatology, nephrology, immunology or dermatology background; advanced degrees beneficial.
• 3–6 years in pharma or translational clinical research.
• Strong knowledge of clinical medicine and project management.
• Effective communication in meetings and with written/oral presentations.
• Experience leading and motivating teams; prior management is a plus.
• Understanding of drug development principles and clinical trial execution.
• Experience across therapeutic areas and stages of development.
• Knowledge of biostatistics, pharmacology, data management, medical writing.
• Understanding of global regulatory requirements; regulatory filings advantageous.
• Familiarity with health economics, budgeting, market research and commercialization.
• Willingness to travel 30% and international travel.

Responsibilities

• Lead design and oversight of global clinical research programs and protocols.
• Advise internal teams and external entities on trial objectives and designs.
• Authors program strategies and oversees pivotal trials for safety and efficacy.
• Interpret Phase I–IV results for regulatory submissions and product value.
• Sign NDA submissions and clinical safety documents.
• Oversee vendor/CRO relationships and governance.
• Support regulatory filings with strategic input and clear communications.

Skills

GCP expertise

Clinical development

Leadership

Communication skills

Strategy & planning

Regulatory submissions

Education

MD/DO

PhD/MPH/MBA (plus)

Tools

Microsoft Office

GxP systems

Job description

Otsuka America Pharmaceutical Inc. seeks a Director, Global Clinical Development to design and oversee clinical research programs for OPDC products, with options to work remotely or in Princeton, NJ or Rockville, MD.

The role focuses on Rheumatology, Immunology and Specialty Medicine, collaborating with regulatory agencies and internal teams. You will lead trial strategies, sign NDA/safety documents, mentor staff, manage CRO/vendor relationships, and support regulatory filings while maintaining