Senior Director, Global Clinical Development – Nephrology & Immunology (Immunology)

Location: Remote within the United States; travel approximately 30–35%.

Salary: $249,973–$388,125 annually, plus incentive opportunity.

Company

Otsuka is a pharmaceutical organization developing and commercializing products through global clinical and regulatory programs.

What you will do

• Lead clinical development strategy and execution from proof of concept through late-stage trials and regulatory submissions.
• Provide medical and scientific leadership to cross-functional study teams, overseeing trial design, conduct, and data interpretation.
• Act as medical lead and subject matter expert for nephrology, immunology, and assigned indications.
• Ensure compliance with GCP, regulatory requirements, and internal processes.
• Develop clinical and regulatory documents, including medical monitoring plans, clinical study reports, INDs, NDAs, and BLAs.
• Lead interactions with health authorities, KOLs, advisory boards, vendors, CROs, and external investigators.

Requirements

• MD or DO preferred, ideally with an immunology, rheumatology, or dermatology background; other clinical or scientific doctorates may be considered with clinical support.
• At least five years of post-academic clinical research experience, with pharmaceutical, clinical practice, or academic translational research experience.
• Advanced knowledge of clinical medicine, clinical pharmacology, drug development, and global regulatory requirements.
• Experience across clinical development phases, including global registration trials, proof of concept, safety evaluation, and lifecycle management.
• Experience leading and motivating internal clinical teams, external investigators, consultants, vendors, and CROs.
• Strong communication, presentation, computer, and Microsoft Office skills.

Nice to have

• PhD, MPH, or MBA.
• Experience with successful regulatory filings.
• Knowledge of biostatistics, data management, medical writing, formulation science, marketing, and commercialization.

Culture & Benefits

• Multidisciplinary matrix environment focused on strategic objectives, patient and customer needs, collaboration, and professional development.
• Medical, dental, vision, and prescription drug coverage.
• Company-provided life, accidental death and dismemberment, and 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.