Remote: Clinical Development Lead – CNS & Digital Medicine

Otsuka America Pharmaceutical Inc.; Topeka (KS); Remote; USD 250,000 - 388,000; Full time

Benefits offered by this job

Comprehensive medical

Dental

Tuition reimbursement

401(k) match

Paid holidays

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Clinical Development. The role can be remote or based in Rockville, MD or Princeton, NJ, leading clinical research programs for OPDC products and overseeing NDAs and regulatory filings.

The incumbent will guide development across CNS and digital medicine, coordinate with cross-functional teams, and travel about 30% to collaborate with investigators and regulators globally.

Qualifications

• A clinician (MD, or DO) preferably a psychiatrist or neurologist with management experience.
• 6–9 years in pharma or academic translational clinical research for Senior Director level.
• Thorough knowledge of clinical medicine and science management.
• Excellent written and verbal communication; proficient with MS Office.
• Experience leading and motivating teams; may include personnel management in future.

Responsibilities

• Designs and oversees clinical research programs and protocols for OPDC products.
• Evaluates CNS and Digital Medicine products across development stages for global markets.
• Leads regulatory filings and interacts with regulatory agencies where needed.
• Provides strategic direction in vendor/CRO relationships and governance.
• Supports regulatory filings and medical writing to communicate trial results clearly.

Skills

Clinical trial leadership

Medical/scientific consultancy

Regulatory filings

Biostatistics knowledge

Pharmacology understanding

Travel 30%+

Communication skills

MS Office

Education

MD/DO

Supplementary degrees (PhD/MPH/MBA)

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Job description

Otsuka America Pharmaceutical Inc. is seeking a Senior Director, Global Clinical Development. The role can be remote or based in Rockville, MD or Princeton, NJ, leading clinical research programs for OPDC products and overseeing NDAs and regulatory filings.

The incumbent will guide development across CNS and digital medicine, coordinate with cross-functional teams, and travel about 30% to collaborate with investigators and regulators globally.