Caralee Schaefer
Vice President, Nonclinical Development @Quince Therapeutics
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WORK HISTORY
Vice President, Nonclinical Development @Quince Therapeutics
South San Francisco, CA, US
EDUCATION
Wayne State University School of Medicine
PhD, Immunology
Adrian College
BS, Biology/Chemistry
Parke-Davis/Warner Lambert
Post Doctoral Fellowship, Pharmacology and Inflammation Research
SKILLS
ABOUT CARALEE SCHAEFER
Seasoned leader with more than 25 years of nonclinical development experience across small molecules, biologics, and gene therapy platforms. Comprehensive expertise spanning pharmacology, toxicology, clinical pharmacology, biomarker development, and safety pharmacology. Extensive record of leading the preparation, authorship, and strategic integration of regulatory submissions—including INDs, NDAs, and associated briefing packages—ensuring alignment with evolving FDA and global regulatory expectations. Demonstrated expertise in nonclinical development of novel therapies to address the high unmet medical need for the treatment of inflammation, autoimmunity, fibrosis, rare disease, and cancer, resulting in the successful submission of 15 INDs and 3 NDAs. Driven to provide strategic leadership and successful execution of nonclinical safety and toxicology across all stages of drug development, from early discovery and IND planning through late‑stage clinical development and approval. Recognized for exceptional cross functional leadership, uncompromising scientific rigor, and the ability to build and inspire high performing teams that accelerate and de-risk pipeline progression.
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