Angela Nunez
Study Director Medical Device Biocompatibility @Labcorp
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WORK HISTORY
Study Director Medical Device Biocompatibility @Labcorp
Bedford, MA, US
Labcorp (CRO)Act as the Single Point of Study Control for high-complexity safety evaluations, specializing in blood-device interactions and tissue integration for Class test medical devices.In Vivo Thromboresistance: Directing complex In Vivo Thrombo evaluations to assess the thrombogenic potential of cardiovascular and neurovascular devices per ISO 10993-4.Long & Short-Term Implantation: Leading high-stakes In Vivo Implantation portfolios (ISO 10993-6), managing surgical execution and local tissue response evaluation for orthopedic and permanent implants (up to 12+ months).Specialized Toxicity (TOS): Overseeing specialized Toxicity protocols to provide critical systemic safety data for global regulatory dossiers (FDA, and EPA).Regulatory Strategy (BEP/BER): Partnering with global sponsors to develop Biological Evaluation Plans, translating device material specs into GLP-compliant study designs for high-risk device submissions.Operational Leadership: Leveraging an MBA in Healthcare Management to optimize study lifecycles, manage resource allocation, and drive digital data integrity through ELN/LIMS platforms.Technical Problem Solving: Utilizing 23 years of preclinical experience to troubleshoot anomalous biological findings in large animal models, ensuring scientific rigor and study validity.
EDUCATION
Southern New Hampshire University
Master of Business Administration - MBA, Health/Health Care Administration/Management
Northern Essex Community College
Associate's degree, Art/Art Studies, General
Southern New Hampshire University
Bachelor of Business Administration - BBA, Health/Health Care Administration/Management
ABOUT ANGELA NUNEZ
I am a Strategic Preclinical Leader with 23 years of experience bridging the gap between high-stakes science and operational excellence. My expertise lies in navigating the complex global regulatory landscapes (FDA, EPA, ISO 10993) required to move next-generation therapies from the lab to the clinic.Throughout my career across academic, pharmaceutical, and biotechnology settings, I have specialized in:• Advanced Therapeutics: Directing complex in vivo biocompatibility for CAR-T/NK therapies and large animal models.• Regulatory Mastery: Leading end-to-end study lifecycles for submissions under ISO 10993 and USP Class Testing (I–VI).• Business Acumen: Leveraging an MBA in Healthcare Management to optimize operational budgets, scale laboratory management, and ensure digital data integrity (ELN/LIMS).My profile is unique because I speak both \"science\" and \"business.\" I don’t just manage studies; I translate complex preclinical data into the strategic insights that enable data-driven decision-making and accelerated clinical timelines.Core Competencies:Preclinical Pharmacology Strategy | GxP Laboratory Management | Global Regulatory Submissions | Data-Driven Decision-Making | People Management | Digital Transformation (LIMS/ELN)| Small & Large Molecule Therapeutics.
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