Remote Global Clinical Development Director

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

Job summary

Otsuka America Pharmaceutical Inc. seeks an Associate Director/Director/Senior Director, Global Clinical Development, located in Rockville, MD or Princeton, NJ.

You will design and oversee clinical research programs for OPDC products, focusing on CNS and digital medicine, and provide strategic direction for regulatory filings and vendor governance. You will lead multidisciplinary teams, collaborate with regulatory agencies, physicians, and scientists, and drive life-cycle strategies to deliver

Qualifications

• Clinician with MD/DO, psychiatry/neurology preferred, plus management experience.
• Experience in pharmaceutical industry or translational clinical research, 6+ years typical.

Responsibilities

• Designs and oversees clinical research programs and protocols for OPDC products.
• Evaluates and develops CNS and digital medicine products for global markets.
• Authors and oversees program strategies (GDCP) and essential trials.
• Interprets Phase I–IV results for regulatory submissions.
• Signatory on NDA submissions and clinical study documents.
• Provides strategic oversight of vendor and CRO relationships.
• Leads regulatory filing activities and provides clear argumentation.

Skills

Clinical leadership

GCP knowledge

Regulatory understanding

Communication skills

Team leadership

Vendor/CRO management

Strategic thinking

Education

MD/DO degree

Supplementary degrees (PhD/MPH/MBA)

Other clinical doctorates considered

Tools

Microsoft Office

Job description

Otsuka America Pharmaceutical Inc. seeks an Associate Director/Director/Senior Director, Global Clinical Development, located in Rockville, MD or Princeton, NJ.

You will design and oversee clinical research programs for OPDC products, focusing on CNS and digital medicine, and provide strategic direction for regulatory filings and vendor governance. You will lead multidisciplinary teams, collaborate with regulatory agencies, physicians, and scientists, and drive life-cycle strategies to deliver