Global Clinical Development Lead, CNS & Digital Medicine

Otsuka America Pharmaceutical Inc.; Salem (OR); On-site; USD 180,000 - 260,000; Full time

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Associate Director/Director/Senior Director, Global Clinical Development to design and oversee clinical programs for OPDC products, focused on CNS and digital medicine, with NDA submissions and global development plans.

Role based in Rockville, MD or Princeton, NJ with remote work options. The incumbent will guide cross-functional teams, manage vendor/CRO relationships and contribute to regulatory filings, while traveling up to 30% to support

Qualifications

• A clinician (MD/DO) preferably psychiatry or neurology with prior management experience.
• 6+ years in pharma industry or academic translational clinical research.
• Strong knowledge of clinical medicine and science management; ability to drive business outcomes.

Responsibilities

• Designs and oversees clinical research programs and protocols for OPDC products.
• Responsible for evaluation and clinical development of CNS and Digital Medicine products across development stages.
• Lead and support regulatory filing activities and documents; provide strategic direction and editing for communications.
• Provide strategic oversight in vendor and CRO relationships and governance.
• Interacts with regulatory agencies and internal teams to ensure trial objectives and timelines are met.
• Travel approximately 30% domestically and internationally.

Skills

Physician MD/DO

Psychiatry

Neurology

Management experience

Clinical research experience

Pharma industry exposure

MS Office

Education

MD/DO required

PhD/MPH/MBA a plus

Tools

Microsoft Office

Job description

Otsuka America Pharmaceutical Inc. is seeking an Associate Director/Director/Senior Director, Global Clinical Development to design and oversee clinical programs for OPDC products, focused on CNS and digital medicine, with NDA submissions and global development plans.

Role based in Rockville, MD or Princeton, NJ with remote work options. The incumbent will guide cross-functional teams, manage vendor/CRO relationships and contribute to regulatory filings, while traveling up to 30% to support