Remote Senior Director, Global Clinical Development

Otsuka America Pharmaceutical Inc.; Augusta (ME); Remote; USD 180,000 - 290,000; Full time

Job summary

Otsuka Pharmaceutical Company is seeking a Senior Director, Global Clinical Development for remote work or based in Rockville, MD or Princeton, NJ. You will design and oversee global clinical development programs for OPDC products, driving strategic plans and high-quality studies to support regulatory filings.

The role requires deep clinical and translational science expertise, leadership across functions, and interstate/international collaboration with teams and regulators.

Qualifications

• MD or DO with clinical specialty preferred.
• Experience in pharma industry or academic translational clinical research.
• Strong communication and leadership skills.
• Understanding of regulatory filings and health value creation.
• Willingness to travel 30% of the time and ability to travel internationally.

Responsibilities

• Designs and oversees clinical research programs and protocols.
• Develops GDCP strategies, protocols, and study reports.
• Interprets Phase I–IV results for regulatory submissions.
• Acts as signatory on NDA submissions and safety documents.
• Oversees vendor and CRO relationships and governance.
• Supports regulatory filing activities and documentation.

Skills

Clinical leadership

Medical knowledge

Regulatory strategy

Cross-functional collaboration

Team management

Health economics

Global development

Education

MD/DO

PhD/MPH/MBA considered

Tools

Word

Excel

PowerPoint

Outlook

Job description

Otsuka Pharmaceutical Company is seeking a Senior Director, Global Clinical Development for remote work or based in Rockville, MD or Princeton, NJ. You will design and oversee global clinical development programs for OPDC products, driving strategic plans and high-quality studies to support regulatory filings.

The role requires deep clinical and translational science expertise, leadership across functions, and interstate/international collaboration with teams and regulators.