Global Clinical Development Director, CNS & Digital Medicine

Sustainable World, Inc.; New Jersey; Hybrid; USD 180,000 - 300,000; Full time

Job summary

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) seeks a Director, Global Clinical Development to design and oversee clinical programs for CNS and Digital Medicine products across global trials.

You will collaborate with clinical, regulatory and scientific leaders to optimize trial objectives, develop GDCP strategies, and prepare NDA submissions, while guiding vendor and CRO relationships and supporting regulatory filings to ensure timely, quality outcomes.

Qualifications

• Clinicians with advanced medical/scientific training and leadership experience.
• Experience in pharma/clinical research and regulatory affairs advantageous.
• Ability to communicate clearly in written and oral presentations.

Responsibilities

• Designs and oversees clinical research programs and protocols for OPDC products.
• Consults with clinical, regulatory and scientific leaders to optimize trial objectives and designs.
• Authors program strategies (GDCP) and oversees trials for safety, efficacy and value assessments.
• Interprets Phase I–IV results for NDA submissions and regulatory filings.
• Provides strategic oversight of vendor and CRO relationships and supports regulatory filings.

Skills

Clinical leadership

Regulatory knowledge

Team management

Scientific communication

Cross-functional collaboration

Education

MD/DO

PhD/MPH/MBA

Tools

Microsoft Office

Job description

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) seeks a Director, Global Clinical Development to design and oversee clinical programs for CNS and Digital Medicine products across global trials.

You will collaborate with clinical, regulatory and scientific leaders to optimize trial objectives, develop GDCP strategies, and prepare NDA submissions, while guiding vendor and CRO relationships and supporting regulatory filings to ensure timely, quality outcomes.