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

  • Company: Otsuka America Pharmaceutical Inc.
  • Location: Washington, D.C., US

Otsuka America Pharmaceutical Inc. at a glance

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Federal funding recipient: largest known award $638K from the Department of Veterans Affairs (started Oct 1, 2024) — via USAspending.gov

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Join Otsuka America Pharmaceutical Inc. as Director, Early Clinical Development – Nephrology/Immunology (N/I), a full-time strategic leadership role based in Washington, D.C., US. You'll drive clinical development initiatives that advance our pipeline of novel therapies in nephrology and immunology.

About the Role

This is a senior scientific and clinical leadership position within our Early Development Organization. Reporting to the Therapeutic Area Head for Nephrology/Immunology, you will oversee the full scope of early clinical development activities—from preclinical transition through Phase II—ensuring alignment with Otsuka's discovery objectives and commercial strategy. You'll be the strategic architect behind our early-phase programs, accountable for clinical outcomes, timelines, budgets, and the scientific rigor that positions our molecules for success.

What You'll Do

  • Lead clinical development strategy and execution for early-phase programs in nephrology and immunology therapeutics
  • Manage cross-functional teams of scientists, clinicians, and project managers to deliver on development milestones
  • Develop and oversee clinical trial designs, protocols, and regulatory strategies in partnership with regulatory affairs
  • Review clinical and translational data to inform go/no-go decisions and program prioritization
  • Represent early development at strategic portfolio meetings and leadership forums
  • Build and mentor a high-performing team while fostering scientific excellence and innovation
  • Ensure compliance with regulatory requirements and internal governance standards

What We're Looking For

  • MD, PhD, or equivalent advanced degree in a life sciences discipline
  • 10+ years of pharmaceutical or biotech early clinical development experience
  • Demonstrated expertise in nephrology, immunology, or related therapeutic areas
  • Proven track record leading clinical programs from IND through Phase II
  • Strong knowledge of regulatory processes, including FDA interactions and IND/CTA submissions
  • Excellent scientific judgment, strategic thinking, and decision-making in ambiguous environments
  • Excellent communication and cross-functional leadership skills
  • Ability to work independently while collaborating across global functions

About Otsuka America Pharmaceutical Inc.

Otsuka America Pharmaceutical Inc. is part of the Otsuka Pharmaceutical family, a global innovator committed to developing breakthrough medicines across multiple therapeutic areas. Our Early Development Organization advances a robust pipeline of promising candidates in oncology, immunology, nephrology, and other areas of high unmet medical need. We foster a culture of scientific rigor, collaboration, and patient-centric innovation.

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.

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Washington, D.C., officially the District of Columbia and commonly known as Washington or D.C., is the capital city and federal district of the United States. The city is on the Potomac River across from Virginia and shares land borders with Maryland to its north and east. It was named after George Washington, a Founding Father and the first president of the United States. The district is named fo

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