Donald Munroe

Donald Munroe Email and Phone Number

Principal and Founder @ Stratagem Healthworks, LLC
Tucson, AZ, US
Donald Munroe's Location
Sparks Glencoe, Maryland, United States, United States
Donald Munroe's Contact Details
About Donald Munroe

Dynamic and results-driven healthcare executive with a proven track record in In Vitro Diagnostics, Life Sciences, and AI/Informatics workflow technologies. Recognized for delivering transformative business outcomes through innovative design, development, and global commercialization of FDA-regulated IVD and AI-powered diagnostics.Expert in defining and executing product strategy, technology roadmaps, and lean-agile development while fostering high-performing teams and operational excellence. Adept at building strategic clinical and academic partnerships, with a customer-centric approach that accelerates adoption and drives measurable commercial success.Highly skilled in leveraging evidence generation, including clinical trials, health economics, and utility studies, to influence key opinion leader advocacy, secure payer reimbursement decisions, and achieve inclusion in clinical guidelines. Presented to CMS, CLFS, FDA and payers to improve healthcare cost, quality and accessibility.

Donald Munroe's Current Company Details
Stratagem Healthworks, LLC

Stratagem Healthworks, Llc

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Principal and Founder
Tucson, AZ, US
Donald Munroe Work Experience Details
  • Stratagem Healthworks, Llc
    Principal And Founder
    Stratagem Healthworks, Llc
    Tucson, Az, Us
  • Bd
    Ww Vice President, Integrated Diagnostics Solutions
    Bd May 2023 - Present
    Franklin Lakes, New Jersey, Us
  • Roche Tissue Diagnostics
    Vp Research & Early Development
    Roche Tissue Diagnostics Jun 2016 - Mar 2023
    Responsible for research and early development of new products and innovative technologies. Ventana Medical Systems, Inc., a member of the Roche Group, is a world leader and innovator of tissue-based diagnostic solutions for patients worldwide.
  • Vermillion, Inc.
    Senior Vp Business Development And Chief Scientific Officer
    Vermillion, Inc. Apr 2014 - Jun 2016
    Trumbull, Connecticut, Us
    Vermillion, Inc. is dedicated to improving women's health by providing innovative methods to detect, diagnose, monitor and manage the treatment of gynecologic cancers and other related diseases.Our flagship product, OVA1®, was the first FDA-cleared, multi-biomarker blood test for pre-surgical assessment of malignancy risk for women with ovarian masses.
  • Vermillion, Inc.
    Chief Scientific Officer And Vp Research And Development
    Vermillion, Inc. Sep 2011 - Apr 2014
    Trumbull, Connecticut, Us
    Vermillion, Inc. is dedicated to improving women's health by providing innovative methods to detect, diagnose, monitor and manage the treatment of gynecologic cancers and other related diseases.Our flagship product, OVA1®, was the first FDA-cleared, multi-biomarker blood test for pre-surgical assessment of malignancy risk for women with ovarian masses.
  • Beckman Coulter
    Vice President Of R&D, Immunoassays Business Group
    Beckman Coulter Jan 2009 - Jul 2011
    Brea, California, Us
    Responsibility for assay development, improvement and support for 60+ commercialized Immunoassays on automated DxI and Access platforms, and manual microplates. The immunoassays ranged from PMA, to 510(k) and RUO assays for cardiac, endocrine, reproductive, oncology and many other important medical needs. Additional technical responsibilities included Biostatistics, Technical Investigations and at times, Clinical Research.
  • Self Employed
    Biotech / Molecular Diagnostics Executive
    Self Employed Feb 2008 - Dec 2008
    Molecular Diagnostics Strategic Consultant* Business and Technology Strategic Planning* Competitive Analysis and Market-Driven Innovation Levers* Regulatory & Reimbursement Integration into R&D* Partnering Value Proposition & Options Analysis* Program Rescue and Execution Effectiveness
  • Life Technologies
    Vp, Research & Development
    Life Technologies Feb 2004 - Jan 2008
    Waltham, Ma, Us
    * Served two years as leader of Invitrogen's Global Program and Portfolio Management group, managing Innovation across 15 business segments* Implemented a global phase-gated product development process, R&D metrics and targets, and a company-wide annual Program planning & budgeting process* Set global targets for New Product revenue and managed execution via a network of embedded partners, resulting in a 36% gain in new product revenue (2005 vs 2004)* Since Jan 2006, served as R&D Leader for Transplant Diagnostics across teams in Milwaukee, Carlsbad, CA and Liverpool, UK* Introduced high revenue impact IVD and Research use products, including Invitrogen's first automated 96-well microarray chip / processor / imaging system for HLA antibody analysis
  • Life Technologies
    Director, Research & Development (Gibco™)
    Life Technologies Mar 2002 - Feb 2004
    Waltham, Ma, Us
    * As R&D Director for GIBCO™, introduced innovative products like TrypLE™, Reduced Serum Media and PERC.6 BioProduction Media* Streamlined New Product Introduction SOP while maintaining ISO and GMP standards* Implemented Project Management and Design of Experiments, reducing cycle time from 36 months to 9 months
  • Corning Inc
    Director, Technology Commercialization
    Corning Inc Jun 2000 - Mar 2002
    Corning, New York, Us
  • Nps Pharmaceuticals / Allelix Biopharmaceuticals
    Manager, Discovery Biology
    Nps Pharmaceuticals / Allelix Biopharmaceuticals May 1996 - Jun 2000
    Bedminster, New Jersey, Us
    * Gene discovery & target validation* Patents filed, papers published in PNAS on novel drug targets* Project and R&D management* Inflammation, Gastrointestinal and Neuroscience therapeutic areas
  • Rw Johnson Pharmaceutical Research Inst
    Research Scientist
    Rw Johnson Pharmaceutical Research Inst Dec 1990 - Dec 1995
    * Started as a Postdoctoral Fellow sponsored by N.S.E.R.C. Industrial post-doctoral grant* Won employment as Research Scientist* Focused on novel gene cloning, functional genomics, target validation* First author of an invited review on non-steroidal anti-inflammatory drugs (NSAIDs) in Chemistry & Biology

Donald Munroe Skills

Biotechnology Commercialization R&d Medical Devices Lifesciences Validation Molecular Biology Oncology Hardware Diagnostics Immunoassays Product Launch Technology Transfer Program Management Biopharmaceuticals Fda Cross Functional Team Leadership Strategy Genomics Regulatory Affairs Cell Product Development Infectious Diseases Proteomics Gmp Iso 13485 Patents Quality System Portfolio Management Six Sigma Organizational Design Executive Management Immunology Market Development Disruptive Technologies Antibodies Diagnostics Technology Commercialization 510 K Pma Patent Strategy Dfss Organizational Effectiveness Performance Metrics Voice Of The Customer Lean Development Ivdmia Multivariate Testing Instrument Systems Life Sciences Protein Chemistry

Donald Munroe Education Details

  • University Of Toronto
    University Of Toronto
    P53 Tumor Suppressor
  • Mcmaster University
    Mcmaster University
    X-Linked Inactivation
  • University Of Guelph
    University Of Guelph
    Psychology
  • Westdale Secondary
    Westdale Secondary

Frequently Asked Questions about Donald Munroe

What company does Donald Munroe work for?

Donald Munroe works for Stratagem Healthworks, Llc

What is Donald Munroe's role at the current company?

Donald Munroe's current role is Principal and Founder.

What is Donald Munroe's email address?

Donald Munroe's email address is k1****@****hoo.com

What is Donald Munroe's direct phone number?

Donald Munroe's direct phone number is +151251*****

What schools did Donald Munroe attend?

Donald Munroe attended University Of Toronto, Mcmaster University, University Of Guelph, Westdale Secondary.

What skills is Donald Munroe known for?

Donald Munroe has skills like Biotechnology, Commercialization, R&d, Medical Devices, Lifesciences, Validation, Molecular Biology, Oncology, Hardware Diagnostics, Immunoassays, Product Launch, Technology Transfer.

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