Senior Director, Global Clinical Development — Remote

Otsuka America Pharmaceutical Inc.; Phoenix (AZ); Remote; USD 180,000 - 280,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development for remote work or in Rockville, MD or Princeton, NJ.

You will design, oversee, and optimize global clinical development programs for OPDC products and ensure high-quality regulatory submissions across multiple pathways. You will lead a team of clinicians and scientists, collaborate with medical affairs, regulatory, and commercial teams, and drive strategy from early development to post-market studies with a

Qualifications

• MD/DO or equivalent clinical degree required with management experience.
• Experience in pharmaceutical industry or translational clinical research.
• Strong communication skills for meetings, written and oral presentations.

Responsibilities

• Design and oversee global clinical development programs for OPDC products.
• Author GDCP strategies, protocols, and study reports; guide trials end-to-end.
• Lead NDA submissions and regulatory filings; coordinate with regulatory agencies.
• Oversee vendor and CRO relationships; provide clinical input to governance forums.
• Travel approximately 30% domestically and internationally.

Skills

Clinical development leadership

Regulatory strategy

Medical/clinical writing

Team management

Cross-functional collaboration

GCP knowledge

Education

MD/DO

PhD/MPH/MBA (plus)

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Outlook

Job description

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development for remote work or in Rockville, MD or Princeton, NJ.

You will design, oversee, and optimize global clinical development programs for OPDC products and ensure high-quality regulatory submissions across multiple pathways. You will lead a team of clinicians and scientists, collaborate with medical affairs, regulatory, and commercial teams, and drive strategy from early development to post-market studies with a