Global Clinical Development Lead - Senior Director (Remote)

Otsuka America Pharmaceutical Inc.; Hagåtña (GU); Remote; USD 180,000 - 270,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development to lead design and oversight of clinical programs for OPDC products. The role can be remote or based in Rockville, MD or Princeton, NJ, focusing on CNS and digital medicine development for global markets.

You will drive strategic studies, author GDCP plans, and manage NDA submissions, safety documents, and vendor relationships, advancing new therapies with rigorous clinical standards.

Qualifications

• Clinician with management experience; MD/DO preferred.
• Experience in pharma or translational clinical research.
• Strong written and verbal communication.
• Ability to travel ~30% domestically and internationally.

Responsibilities

• Design and oversee clinical research programs and protocols for OPDC-GCD.
• Evaluate and develop CNS and Digital Medicine products across development stages.
• Consult with patients, regulatory, medical affairs, and other leaders to optimize trials.
• Authors program strategies, protocols, and study reports for regulatory submissions.
• Lead NDA submissions and clinical safety documents; support filings.
• Provide strategic oversight of vendor and CRO relationships.

Skills

Clinical development

Regulatory filings

Team leadership

GCP compliance

Medical writing

Biostatistics knowledge

Project management

Communication skills

Strategic planning

Travel willingness

Education

MD or DO

PhD / MPH / MBA beneficial

Tools

Microsoft Office

Job description

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development to lead design and oversight of clinical programs for OPDC products. The role can be remote or based in Rockville, MD or Princeton, NJ, focusing on CNS and digital medicine development for global markets.

You will drive strategic studies, author GDCP plans, and manage NDA submissions, safety documents, and vendor relationships, advancing new therapies with rigorous clinical standards.