Remote Senior Director, Immunology Clinical Development

Otsuka America Pharmaceutical Inc.

Trenton (NJ)

Remote

USD 250,000 - 388,000

Full time

14 days+
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Benefits offered by this job

Medical, dental, vision coverage
401(k) with company match

Job summary

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development with immunology expertise to lead global clinical strategy across programs and oversee OPDC product development under GCP.

You will steer cross‑functional study teams, contribute to regulatory filings, and shape publication plans while mentoring junior staff and collaborating with regulatory affairs. This role requires deep drug development knowledge, leadership across therapeutic areas, and global launch

Qualifications

  • A clinician (MD/DO) with immunology/rheumatology/dermatology background and management experience.
  • Minimum five years in clinical research, pharmaceutical industry, or translational research.
  • Thorough knowledge of clinical medicine, pharmacology, biostatistics, data management, medical writing.
  • Strong understanding of global regulatory requirements and drug development lifecycle.

Responsibilities

  • Lead clinical development strategy and execution from proof-of-concept through late-stage trials.
  • Provide medical leadership to cross-functional study teams and ensure high-quality trial design and data interpretation.
  • Serve as medical lead for assigned indications and oversee regulatory document development.
  • Collaborate with regulatory affairs for global health authority interactions.
  • Oversee vendor and CRO governance and contribute to publication planning.
  • Mentor junior team members and support business development due diligence.

Skills

Immunology expertise
Clinical leadership
Regulatory strategy
Cross-functional team leadership
Strategic thinking

Education

MD/DO (immunology/rheumatology/dermatology preferred)
PhD, MPH or MBA a plus

Tools

MS Word
Excel
PowerPoint
Outlook

Job description

Otsuka America Pharmaceutical Inc. seeks a Senior Director, Global Clinical Development with immunology expertise to lead global clinical strategy across programs and oversee OPDC product development under GCP.

You will steer cross‑functional study teams, contribute to regulatory filings, and shape publication plans while mentoring junior staff and collaborating with regulatory affairs. This role requires deep drug development knowledge, leadership across therapeutic areas, and global launch

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