Remote Global Clinical Development Director (CNS & Digital)

Otsuka America Pharmaceutical Inc.; Honolulu (HI); On-site; USD 210,000 - 313,000; Full time

Job summary

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

You will design and oversee clinical research programs and protocols for OPDC products under GCP, focusing on CNS and Digital Medicine across development stages for a global health-care market. You will consult with clinicians and regulatory leaders, author program strategies, oversee trials, and provide strategic input to vendors and

Qualifications

• A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus.
• Experience in the pharmaceutical industry or in academic translational clinical research 6+ years is typically required depending on type of experience at application.
• Knowledge of clinical medicine and science management with focus on achieving business outcomes.
• Excellent written and oral communication in meetings and in presentations; proficient with Microsoft Office suite.
• Demonstrated experience leading, managing and motivating team members; travel 30% of time, weekends, international travel.

Responsibilities

• Designs and oversees clinical research programs and protocols for OPDC products under GCP.
• Evaluates and develops clinical development strategies for CNS and Digital Medicine products across development stages.
• Authors GDCP program strategies and oversees trials essential for determining safety, efficacy, and value of products.
• Interprets results of Phase I-IV investigations for NDA submissions and regulatory communications.
• Leads and supports regulatory filing activities and provides strategic direction for written and verbal communications.
• Provides vendor and CRO governance input and strategic oversight.

Skills

Global clinical development

Clinical leadership

Team management

Regulatory filings

Communication skills

Biostatistics knowledge

CNS/digital medicine knowledge

Education

M.D. or D.O.

Supplementary degrees (Ph.D./MPH/MBA)

Tools

Microsoft Office

Job description

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

You will design and oversee clinical research programs and protocols for OPDC products under GCP, focusing on CNS and Digital Medicine across development stages for a global health-care market. You will consult with clinicians and regulatory leaders, author program strategies, oversee trials, and provide strategic input to vendors and