Clinical Development Director, CNS & Digital Medicine

Careerwebsite; Trenton, Northern (NJ, KY); Hybrid; USD 180,000 - 260,000; 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. You will craft GDCP strategies, oversee trials, and liaise with regulatory bodies to support global submissions.

The role requires M.D./D.O. with leadership experience, strong clinical and scientific knowledge, and the ability to manage cross-functional teams.

Qualifications

• Clinician with MD/DO, board certification preferred in nephrology, immunology, or dermatology.
• Experience in pharma or translational clinical research (Associate Director to Senior Director level).
• Strong written and oral communication; proficient with MS Office and medical writing.
• Leadership experience managing teams or external investigators is a plus.

Responsibilities

• Designs and oversees clinical research programs and protocols.
• Evaluates clinical development of CNS and Digital Medicine products.
• Leads NDA submissions and safety documentation.
• Interprets Phase I–IV results for regulatory filings and product strategy.
• Provides strategic direction for vendor/CRO governance and collaborations.
• Supports regulatory filings and develop GDCP plans.

Skills

Clinical trial leadership

Interdisciplinary collaboration

Regulatory knowledge

Medical writing

Excellent communication

Education

MD/DO degree

PhD/MPH/MBA a plus

Tools

Microsoft Word

PowerPoint

Excel

Outlook

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. You will craft GDCP strategies, oversee trials, and liaise with regulatory bodies to support global submissions.

The role requires M.D./D.O. with leadership experience, strong clinical and scientific knowledge, and the ability to manage cross-functional teams.