Remote Senior Director, Global Clinical Development

Otsuka America Pharmaceutical Inc.; Boise (ID); Remote; USD 180.000 - 320.000; Vollzeit

Zusammenfassung

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Clinical Development.

This remote-based role or based in Rockville, MD or Princeton, NJ will design and oversee clinical programs for OPDC products under GCP, with a focus on CNS and Digital Medicine for a global health-care market. You will collaborate with clinical, regulatory, medical affairs, and research teams, lead development plans, and guide regulatory filings.

Qualifikationen

• MD/DO physician with strong clinical medicine knowledge and leadership skills.
• Experience in pharmaceutical industry or academic translational clinical research, 6–9 years for Senior Director level.
• Ability to define objectives clearly and manage projects to time, budget and quality.
• Excellent written and oral communication; proficient with MS Office suite.
• Demonstrated experience leading, managing and motivating teams and external investigators or consultants.
• Understanding of health value creation, regulatory filings, and market strategies.

Aufgaben

• Designs and oversees clinical research programs and protocols for OPDC products under GCP.
• Evaluates and develops CNS and Digital Medicine products across development stages for a global market.
• Leads regulatory filings and contributes to NDA submissions and safety documents.
• Provides strategic direction and governance in vendor/CRO relationships.
• Travels up to 30% domestically and internationally to support development programs.

Kenntnisse

Leadership

Communication

Clinical development expertise

Project management

Regulatory filings knowledge

Travel readiness

Ausbildung

MD/DO

PhD/MPH/MBA (plus)

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Jobbeschreibung

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Clinical Development.

This remote-based role or based in Rockville, MD or Princeton, NJ will design and oversee clinical programs for OPDC products under GCP, with a focus on CNS and Digital Medicine for a global health-care market. You will collaborate with clinical, regulatory, medical affairs, and research teams, lead development plans, and guide regulatory filings.