Senior Director, Global Clinical Development – Nephrology & Immunology

Job Description

Otsuka is seeking an experienced Senior Director, Global Clinical Development (GCD) with a background in immunology to lead the design, execution, and oversight of global clinical development programs. The role involves shaping clinical strategy, leading cross‑functional teams, and ensuring scientific and medical integrity.

The Senior Director, GCD will oversee all clinical development activities for assigned projects, from proof of concept through late‑stage trials and regulatory submissions, culminating in NDA, BLA, or global filings. The role requires strong experience across the drug development lifecycle, a deep understanding of regulatory requirements, and leadership skills.

• Lead clinical development strategy and execution for assigned programs through late‑stage trials and regulatory submissions.
• Provide medical and scientific leadership to cross‑functional study teams; ensure high‑quality trial design, conduct, and data interpretation.
• Serve as medical lead and subject matter expert for the assigned indications.
• Ensure trials comply with GCP, regulatory requirements, and internal processes.
• Lead and contribute to development of clinical sections of regulatory documents (INDs, IBs, clinical study reports, NDAs/BLAs).
• Collaborate with regulatory affairs on interactions with global health authorities.
• Provide strategic and medical oversight of vendor and CRO relationships and give clinical input into governance committees.
• Lead clinical discussions with key opinion leaders and advisory boards.
• Develop clinical documents, including medical monitoring plans and asset development plans.
• Contribute to publication plans and review scientific manuscripts for publication.
• Mentor and lead junior team members.
• Support business development through medical due diligence and evaluation of external opportunities.
• Contribute to corporate initiatives by participating in continuous process improvement.

• M.D. or D.O. with an immunology, rheumatology, or dermatology background and management experience. Supplementary degrees (Ph.D., M.P.H., M.B.A.) are a plus.
• Five or more years of clinical research experience in the pharmaceutical industry, academic translational research, or clinical practice.
• Thorough knowledge of clinical medicine, pharmacology, and related disciplines (biostatistics, data management, medical writing).
• Advanced understanding of drug development principles and clinical trial implementation.
• Complete understanding of global regulatory requirements and experience with regulatory filings.
• Working knowledge of marketing and commercialization.
• Ability to manage and motivate clinical teams across therapeutic areas and development stages.
• Strong communication and presentation skills.
• Computer proficiency with the Microsoft Office suite.
• Knowledge of applying organizational policy to various situations.

• Travel (approximately 30–35%).
• See separate Physical Demands and Work Environment document for additional details.

• Accountability for Results
• Strategic Thinking & Problem Solving
• Patient & Customer Centricity
• Impactful Communication
• Respectful Collaboration
• Empowered Development

Minimum $ – Maximum $, with incentive opportunity.

Medical, dental, vision, prescription drug coverage, life and disability insurance, tuition reimbursement, student loan assistance, 401(k) match, flexible time off, paid holidays, and other company benefits.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be considered without regard to race, color, sex, gender identity or expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation. Contact Accommodation Request at E