Global Clinical Development Director - Remote

Otsuka America Pharmaceutical Inc.; Santa Fe (NM); Remote; USD 210,000 - 320,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development to lead design and oversight of clinical programs for OPDC. This role may be remote or based in Rockville, MD or Princeton, NJ, and involves global CNS and digital medicine product development during various development stages.

You will guide cross-functional teams, interact with regulators, and drive strategic planning, trials, and regulatory submissions to support clinical advancement and commercialization.

Qualifications

• A clinician (MD/DO) with management experience; supplementary degrees are a plus.
• Experience in the pharmaceutical industry or academic translational clinical research, 6–9 years for Senior Director level.
• Strong knowledge of clinical medicine and science management with focus on timely outcomes.
• Effective communication in meetings and presentations; proficient with Microsoft Office.
• Experience leading and motivating teams; prior personnel management is a plus.
• Advanced understanding of drug development principles and clinical trial execution.
• Willingness to travel up to 30% and travel internationally.

Responsibilities

• Designs and oversees clinical research programs and protocols for OPDC.
• Evaluates CNS and Digital Medicine programs for a global market.
• Consults with patients, clinicians, regulators to optimize trial objectives and plans.
• Authors program strategies, protocols, study reports; oversees trials.
• Interprets Phase I–IV results for NDA submissions.
• Provides strategic direction and edits for regulatory filings and communications.
• Supports vendor/CRO governance and external collaborations.
• Leads regulatory filing activities and contributes to policy discussions.

Skills

Clinical leadership

Team management

Regulatory filings

Communication skills

Biostatistics

Clinical pharmacology

Data management

Medical writing

Formulation science

Education

MD/DO

PhD/MPH/MBA

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Outlook

Job description

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development to lead design and oversight of clinical programs for OPDC. This role may be remote or based in Rockville, MD or Princeton, NJ, and involves global CNS and digital medicine product development during various development stages.

You will guide cross-functional teams, interact with regulators, and drive strategic planning, trials, and regulatory submissions to support clinical advancement and commercialization.