Director, Global Clinical Development (CNS)

Location: Remote, United States; willingness to travel internationally for approximately 30% of the time, including weekends, is required.

Salary: $209,599–$313,375 annually, plus an incentive opportunity.

Company

Otsuka Pharmaceutical Development & Commercialization develops global health-care products through clinical research, scientific evaluation, and commercialization planning.

What you will do

• Design and oversee clinical research programs and protocols for CNS and digital medicine products under good clinical practices.
• Author global development and commercialization plans covering first-in-human, proof-of-mechanism, registrational, and post-approval trials.
• Evaluate and communicate Phase I–IV clinical investigation results related to safety, efficacy, medical usefulness, and product value.
• Act as signatory on NDA submissions, clinical study documents, and safety documents.
• Provide medical and scientific consultation to health economics, medical affairs, marketing, regulatory, statistics, and research teams.
• Provide strategic oversight of vendor and CRO relationships and support regulatory filing activities.

Requirements

• Clinician with an M.D. or D.O.; nephrology or immunology experience is preferred.
• Typically 3–6 years of pharmaceutical industry or academic translational clinical research experience for the Director level.
• Advanced knowledge of drug development principles, clinical trial implementation, management, and reporting.
• Experience leading, managing, and motivating internal staff, investigators, or consultants; prior management experience is preferred.
• Knowledge of global regulatory requirements and related disciplines including biostatistics, clinical pharmacology, data management, formulation science, and medical writing.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook, plus willingness to travel internationally approximately 30% of the time.

Nice to have

• Supplementary degree such as a Ph.D., M.P.H., or M.B.A.
• Experience with successful regulatory filings.
• Experience in financial assessment, project budgeting, market research, and commercialization strategy.

Culture & Benefits

• Collaborative and innovative environment focused on patient and customer needs.
• Medical, dental, vision, and prescription drug coverage.
• Life, accidental death and dismemberment, short- and long-term disability insurance.
• Tuition reimbursement, student loan assistance, and a generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.