Caralee Schaefer, PhD
Vice President, Nonclinical Development
Professional Overview
Caralee Schaefer is an accomplished pharmaceutical executive with over 15 years of experience leading nonclinical development programs. As the Vice President of Nonclinical Development at Quince Therapeutics, she oversees a team responsible for guiding novel drug candidates from the preclinical stage through regulatory approval. Caralee is recognized for her deep expertise in pharmacology, toxicology, and the strategic planning required to advance innovative therapeutics.
Experience Summary
Current Role
In her current role as Vice President of Nonclinical Development at Quince Therapeutics, Caralee is responsible for directing all preclinical activities, including pharmacology and toxicology studies, to support the company's pipeline of novel small molecule and biologic drug candidates. She has successfully led cross-functional teams to achieve critical milestones, including the IND approval of the company's lead program in 2022. Caralee's strategic leadership has been instrumental in Quince Therapeutics' progression as a clinical-stage biopharmaceutical company.
Career Progression
Prior to joining Quince Therapeutics, Caralee held senior leadership positions at several prominent biotechnology companies. As the Senior Director of Pharmacology & Toxicology at 4DMT, she managed all preclinical development activities for the company's gene therapy pipeline. At Cortexyme, Inc. and Indalo Therapeutics, she served as Executive Director of Preclinical Development and Pharmacology, respectively, where she made significant contributions to advancing novel therapeutics for neurodegenerative and fibrotic diseases. Caralee's career trajectory demonstrates her ability to drive the progression of promising drug candidates through the nonclinical development stage.
Academic Background
Caralee holds a PhD in Pharmacology from the University of California, San Francisco, where her research focused on the development of small molecule therapeutics for the treatment of metabolic disorders. She also earned a Bachelor of Science degree in Biochemistry from the University of California, Davis.
Areas of Expertise
- Nonclinical drug development strategy and execution
- Pharmacology and toxicology study design and interpretation
- Regulatory affairs and IND/NDA submission preparation
- Cross-functional team leadership and collaboration
- Project management and portfolio optimization
Professional Impact
Throughout her career, Caralee has made significant contributions to the advancement of innovative therapeutics. She has successfully navigated multiple drug candidates through the nonclinical development stage, leading to the initiation of clinical trials and the achievement of regulatory milestones. Caralee's expertise in pharmacology, toxicology, and strategic planning has been instrumental in driving the progress of promising drug candidates in therapeutic areas such as neurology, fibrosis, and metabolism.
Conclusion
With her extensive experience in nonclinical drug development and a proven track record of success, Caralee Schaefer is a valuable asset to the biopharmaceutical industry. As the Vice President of Nonclinical Development at Quince Therapeutics, she continues to leverage her expertise to guide the company's pipeline of novel therapeutics towards clinical development and regulatory approval, ultimately benefiting patients in need.
