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Clinical Science Leader and Immunology Specialist

2 months ago

Reston, Virginia, United States IGM Biosciences, Inc. Full time

Job Summary

We are seeking a highly skilled and experienced Director/Sr. Director, Clinical Science and Immunology Expert to join our team at IGM Biosciences, Inc. This individual will play a critical role in supporting the development of our IgM-based pipeline molecule clinical trials, including early-phase studies in autoimmune/inflammatory diseases.

Key Responsibilities:

  • Collaborate with cross-functional teams to develop and implement clinical trial strategies and protocols.
  • Lead the development of clinical trial protocols and related documents, ensuring compliance with regulatory requirements.
  • Provide strategic insights and support for literature research, regulatory filings, site and investigator relationships, study data tracking and analysis, and preparation of presentations and publications.

Qualifications and Requirements:

  • 10+ years of clinical trial experience, including in the autoimmune therapeutic areas, with a proven track record of engaging with clinicians and scientists.
  • Advanced scientific or clinical degree preferred (e.g., PhD, PharmD, MPH, MD, RN).
  • In-depth understanding of drug development, including early-phase clinical trial experience and sound knowledge of medical aspects of relevant guidelines and regulations (e.g., GCP, ICH).
  • Clinical research skills, including data listing review, protocol authoring, and data analysis.
  • Able to travel (