Director, Early Clinical Development – Nephrology/Immunology (N/I)

Otsuka America Pharmaceutical Inc. seeks an experienced Director of Early Clinical Development in Nephrology/Immunology (N/I) to lead strategic development initiatives at our Bonnie location. This full-time leadership role offers the opportunity to shape early-phase clinical programs and advance innovative therapies from discovery through IND-enabling studies.

About the Role

As Director of Early Clinical Development for the Nephrology/Immunology therapeutic area, you will oversee the strategic planning, execution, and governance of early clinical programs within our Early Development Organization (EDO). Reporting to the ECD Therapeutic Area Head, you will be accountable for the complete early clinical development strategy that drives the advancement of novel candidates through preclinical and Phase I/IIa stages. This is a hands-on leadership position where your clinical expertise and scientific judgment will directly influence the trajectory of our pipeline.

What You'll Do

• Direct end-to-end early clinical development strategy aligned with company objectives and therapeutic area priorities
• Oversee study design, regulatory strategy, and clinical protocol development for early-phase trials
• Lead cross-functional teams including clinical operations, regulatory affairs, and internal stakeholders
• Evaluate emerging scientific data and clinical evidence to inform program progression decisions
• Partner with discovery and preclinical teams to prepare candidates for clinical development
• Ensure compliance with regulatory requirements and industry standards throughout all development phases
• Champion a culture of scientific rigor and clinical excellence within the EDO

What We're Looking For

• MD, DO, or PhD with extensive experience in clinical development, particularly in early phases
• Demonstrated expertise in nephrology and/or immunology drug development
• At least 10+ years of pharmaceutical or biotech experience with progressive leadership responsibility
• Strong knowledge of IND-enabling studies, regulatory pathways, and FDA guidance documents
• Proven ability to lead cross-functional teams and drive strategic decision-making
• Excellent written and verbal communication skills
• Strategic thinker with the ability to balance scientific rigor with business objectives

About Otsuka America Pharmaceutical Inc.

Otsuka America Pharmaceutical Inc. is committed to delivering innovative medicines across key therapeutic areas. Our commitment to research and development drives the discovery of treatments that address significant unmet medical needs.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.