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

Technical Consultant #2573


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.
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