Remote Senior Director, Global Clinical Development

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

Job summary

Otsuka Pharmaceutical Company seeks a Senior Director, Global Clinical Development, to lead design and oversight of clinical programs for OPDC products. This role can be remote or located in Rockville, MD or Princeton, NJ and requires extensive experience in CNS and digital medicine development.

The candidate will consult with clinical, regulatory, and scientific leaders; author program strategies; oversee trials; and manage regulatory filings, vendor relationships, and lifecycle planning with a

Qualifications

• Clinician (MD or DO) with management experience; other doctorates may be considered if supported.
• 6-9 years pharma/academic translational clinical research experience for Senior Director level.
• Strong knowledge of clinical medicine and science management with focus on business outcomes.
• Excellent communication skills including written and oral presentations; proficient in Microsoft Office suite.
• Demonstrated experience leading and motivating teams.
• Advanced understanding of drug development and clinical trial implementation across therapeutic areas.
• Flexible across therapeutic areas and stages of development.
• Knowledge of health value creation, budgeting, market research and commercialization strategies.
• Willingness to travel 30% of the time, including international travel.

Responsibilities

• Designs and oversees clinical research programs and protocols for OPDC products under GCP.
• Evaluates and develops CNS and Digital Medicine products across development stages.
• Interacts with patients, regulatory, scientific leads; advises on trial objectives and development plans.
• Authors program strategies, protocols, study reports; oversees trials for safety and efficacy.
• Interprets Phase I–IV results for regulatory submissions and development decisions.
• Leads NDA submissions and clinical study documentation; supports lifecycle management.
• Provides strategic oversight of vendor and CRO relationships and governance input.
• Supports regulatory filings with clear, concise communications and edits.

Skills

Clinical leadership

Regulatory filings experience

Cross-functional collaboration

Travel readiness

Strategic planning

Education

MD/DO

Supplementary degrees (PhD/MPH/MBA)

Tools

MS Office

Job description

Otsuka Pharmaceutical Company seeks a Senior Director, Global Clinical Development, to lead design and oversight of clinical programs for OPDC products. This role can be remote or located in Rockville, MD or Princeton, NJ and requires extensive experience in CNS and digital medicine development.

The candidate will consult with clinical, regulatory, and scientific leaders; author program strategies; oversee trials; and manage regulatory filings, vendor relationships, and lifecycle planning with a