Remote Senior Director, Clinical Development – CNS

Otsuka America Pharmaceutical Inc.; Austin (TX); Remote; USD 180,000 - 260,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Clinical Development to lead design and oversight of clinical programs for OPDC products, with a focus on CNS and Digital Medicine in a global market. Remote-based or office-based in Rockville, MD or Princeton, NJ options.

The role requires strong medical/scientific leadership, extensive regulatory experience, and ability to travel up to 30% internationally. A clinician with MD/DO is preferred, with additional degrees a plus.

Qualifications

• Clinician (MD/DO) with psychiatry/neurology background; additional degrees a plus.
• Pharma/academic translational clinical research experience; 6–9 years for Senior Director level.
• Strong knowledge of clinical medicine, science management, and objective-driven execution.
• Excellent communication in meetings and written/oral presentations; proficient with Word, Excel, PowerPoint, Outlook.
• Experience leading, managing, and motivating teams; prior personnel management advantageous.
• Advanced understanding of drug development across stages; adaptable to multiple therapeutic areas.
• Knowledge of biostatistics, clinical pharmacology, formulation science, data management, medical writing.
• Understanding of global regulatory requirements; regulatory filing experience a plus.
• Understanding of health value creation: financial assessment, project planning, market research, commercialization.

Responsibilities

• Design and oversight of clinical research programs and protocols for OPDC products.
• Evaluate and develop CNS and Digital Medicine products for global market.
• Consult with patients, clinicians, regulatory and scientific leaders to optimize objectives.
• Develop program strategies, protocols, study reports, and oversee trials.
• Interpret Phase I–IV results for NDA submissions.
• Sign NDA submissions and safety documents.
• Provide strategic oversight of vendor and CRO relationships.
• Support regulatory filing activities and provide clear written communications.

Skills

Clinical development

Medical leadership

Communication

Regulatory filings

Education

MD/DO

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Job description

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Clinical Development to lead design and oversight of clinical programs for OPDC products, with a focus on CNS and Digital Medicine in a global market. Remote-based or office-based in Rockville, MD or Princeton, NJ options.

The role requires strong medical/scientific leadership, extensive regulatory experience, and ability to travel up to 30% internationally. A clinician with MD/DO is preferred, with additional degrees a plus.