Global Clinical Development Director, CNS & Digital Medicine

Sustainable World, Inc.; Princeton (NJ); Hybrid; USD 180,000 - 230,000; Full time

Job summary

Otsuka seeks a Director, Global Clinical Development based in Rockville, MD or Princeton, NJ to design and oversee CNS and Digital Medicine clinical programs under GCP. The role leads trials from early to late stages, supports regulatory filings, and guides team strategy across medical affairs, regulatory and research groups.

The candidate will manage life-cycle activities, provide clinical input to governance, and travel as needed to advance global development plans.

Qualifications

• A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience.
• Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus.
• In exceptional circumstances, other doctorates may be considered if complemented by a team or consulting clinician.

Responsibilities

• Consults with patients or their representatives, clinical, regulatory and scientific leaders to optimize trial objectives, designs and protocols.
• Develops internal medical/scientific expertise to support health economic, medical affairs, regulatory and other research teams.
• Authors program strategies (e.g., GDCP) and oversees trials to determine safety, efficacy and value of product candidates.
• Interprets and communicates Phase I-IV results for new drug submissions.
• Acts as signatory on NDA submissions and clinical study and safety documents.
• Involved in product life cycle management from early development stages, seeking value-adding innovations.
• Oversees vendor/CRO relationships and contributes to governance.
• Supports regulatory filing activities and provides direction and editing for clear communications.

Skills

Leadership

Clinical development

Regulatory submissions

Vendor/CRO oversight

Education

MD/DO required

PhD/MPH/MBA preferred

Other clinical doctorates considered

Job description

Otsuka seeks a Director, Global Clinical Development based in Rockville, MD or Princeton, NJ to design and oversee CNS and Digital Medicine clinical programs under GCP. The role leads trials from early to late stages, supports regulatory filings, and guides team strategy across medical affairs, regulatory and research groups.

The candidate will manage life-cycle activities, provide clinical input to governance, and travel as needed to advance global development plans.