Ph.D: Development Operations, Clinical Trial Management, Business Strategy, and Entrepreneurial Leadership Expert

Expertise

• 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.

Experience

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

Temple University

• Bachelor of Arts, Neuroscience

The Wharton School - University of Pennsylvania

• Specialization in Entrepreneurship

Awards 

• Innovation Excellence Award, Center for Advancing Innovation
• Innovation Spotlight Award, Center for Advancing Innovation

Publications

• Author and Co-Author of numerous publications in clinical trials, peer-reviewed journals, and white papers.

Education

• 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.