- Oncology and neuroscience program management, including preclinical and clinical development for novel therapeutics.
- Extensive work in the biotech and pharmaceutical landscapes including key industry trends, customer relations, and competitive landscape.
- Data-driven analytics and portfolio insights.
- Early- and late-stage clinical trial management.
- Site feasibility and startup procedures.
- Contract and budget review and negotiations.
- SOP and regulatory management.
ONTX, Inc., Director, Development Operations, 2021 - Present
- Lead operations and strategy for the preclinical and clinical portfolio programs.
- Create regulatory eQMS, SOP library, and risk management program.
- Develop all financial budgets and forecasting.
Catalyst Clinical Research, LLC., Raleigh, NC, 2020 - 2021
Senior Clinical Project Manager and Senior Clinical Scientist
- Operational and strategic management of Phase I/II oncology clinical trials.
- Data review and analyses - working with functional teams.
- Protocol and development plan insight and design.
- Literature reviews and white paper publications.
Translational Drug Development, Scottsdale, AZ, 2017 - 2020
- Senior Clinical Project Manager and Senior Clinical Strategist
- Strategic planning, insight, and management of Phase I/II oncology clinical trials.
- Strategic partnerships and business development.
- Designed clinical research development plans.
- Designed an innovation library for tech collaborations across project portfolios.
Massachusetts General Hospital, Boston, MA Portfolio Manager, 2013 - 2017
- Protocol development, regulatory oversight, SOP development, and quality monitoring.
- Quantitative data analysis and feedback.
- Grant and manuscript writing.
- Establishment of a department CRO, specific to imaging research, awarded NIH/SBIR grants.
University of Pennsylvania, Philadelphia, PA Clinical Project Manager, 2007 - 2013
- The lead of dendritic cell, RNA, and CART-19 oncology trials.
- Regulatory oversight including SOP and DFP management and monitoring.
- Designed studies for the use of cryopreserved cells.
Independent Consulting Services
Kauffman Fellows - Venture Deals Program-Oncology Consultant and Startup Founder
- Founder of AI Diagnostics (in development)
Center for Advancing Innovation-Oncology Consultant
- Develop commercialization and operations strategies for emerging oncology-focused
- biotech/pharma startups.
Penn Biotech Group, The Wharton School-Oncology Consultant
- Designed strategic plan resulting in FDA IND approval for over a $1billion biotech company.
- Designed business optimization models for a virtual IP law firm to increase portfolio
- Developed a marketing plan for a novel assay.
- Analyzed product development to define strategies toward established verticals.
Honors & Publications
Academic and Professional Affiliations
- American Society of Clinical Oncology
University of New England
- Doctorate, Entrepreneurship
University of Pennsylvania
- Master of Liberal Arts, Neuroscience and Bioethics
- Bachelor of Arts, Neuroscience
The Wharton School - University of Pennsylvania
- Specialization in Entrepreneurship
- Innovation Excellence Award, Center for Advancing Innovation
- Innovation Spotlight Award, Center for Advancing Innovation
- Author and Co-Author of numerous publications in clinical trials, peer-reviewed journals, and white papers.
- Ed.D. Entrepreneurship, University of New England, Biddeford, ME
- M. A. Neuroscience and Bioethics, University of Pennsylvania, Philadelphia, PA
- B. A. Neuroscience, Temple University, Philadelphia, PA.