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Be ready to discuss early-phase N/I trial design trade-offs, safety/endpoint strategy, and how you partner with ops and regulators. Reference public Otsuka N/I signals (e.g., Phase 3 VISIONARY/VOYXACT coverage) only as context for the company’s focus—not as insider knowledge. Prepare examples of program decisions you owned end-to-end.
Strong fit if you lead early clinical strategy in nephrology and/or immunology and want a director seat at a large pharma U.S. affiliate with active N/I and broader pipeline activity. Thin public local/culture data for Bonnie—treat site logistics as a must-ask.
As Director, Early Clinical Development (Nephrology/Immunology) at Otsuka America Pharmaceutical Inc., expect to shape early-phase strategy for N/I assets: protocol and study design, cross-functional alignment with clinical ops, regulatory, and medical, interpretation of emerging data, and vendor/investigator engagement. Days mix scientific review, decision meetings, and program risk management rather than pure bench work.
Build depth in early-phase design, nephrology/immunology disease biology, and cross-functional program leadership. Open learning options from the provided list (costs as stated):
Data marks remote as no; expect on-site or hybrid tied to the Utah listing—confirm with Otsuka recruiting.
Director, Early Clinical Development focused on nephrology/immunology (N/I), not a bedside nursing role despite related open-course resources.
See the Otsuka Pharmaceutical Wikipedia page and company news on VOYXACT Phase 3 and other pipeline updates.
Website: otsukaamericapharmaceutical.com
Otsuka Pharmaceutical Co., Ltd. , abbreviated OPC, is a pharmaceutical company headquartered in Chiyoda, Tokyo. The company was established on August 10, 1964.
Public cache only — not an employee review.
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, Utah County 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 Interested candidates should submit their application through this listing. Please include your resume…
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