Lori H.

Vice President, Clinical Affairs

Professional Overview

Lori H. is an accomplished pharmaceutical and biotechnology professional with over a decade of diverse experience in clinical affairs, research, and medical writing. As the Vice President of Clinical Affairs at ONL Therapeutics, she oversees the strategic direction and execution of the company's clinical development programs, driving innovative therapies to address unmet medical needs.

Experience Summary

Current Role

As the Vice President of Clinical Affairs at ONL Therapeutics, Lori is responsible for leading the company's clinical research and development initiatives. She oversees the design, implementation, and management of clinical trials, ensuring adherence to regulatory guidelines and the delivery of high-quality data. Lori's extensive experience in rare disease drug development has been instrumental in advancing ONL Therapeutics' pipeline of investigational therapies.

Career Progression

Prior to her current role, Lori held several leadership positions in the pharmaceutical industry, including Director of Clinical Affairs at ONL Therapeutics, Director of Clinical Study Team Lead - Rare Disease at Pfizer, and Associate Director of Clinician, Early Clinical Development at Pfizer. She has also served as a Research Consultant at Advarra and a Medical Writing Specialist at Protara Therapeutics, honing her expertise in clinical research, regulatory affairs, and medical communications.

Academic Background

Lori holds a Bachelor of Science degree in Biology from the University of Michigan, where she graduated with honors. Her strong academic background and passion for scientific research have been the foundation for her successful career in the pharmaceutical and biotechnology industries.

Areas of Expertise

• Clinical trial design and management

• Regulatory compliance and submission preparation

• Rare disease drug development

• Medical writing and publication support

• Cross-functional team leadership and collaboration

Professional Impact

Lori's exceptional leadership and technical expertise have resulted in several notable achievements throughout her career. She has contributed to the successful advancement of multiple investigational therapies through the clinical development process, leading to regulatory approvals and improved patient outcomes. Lori's industry contributions include the publication of peer-reviewed articles in respected scientific journals and the presentation of her research at leading industry conferences.

Conclusion

With her extensive experience, strategic vision, and commitment to excellence, Lori H. is poised to continue her impactful work at ONL Therapeutics, driving the development of innovative therapies and advancing the field of pharmaceutical research and development.