Lyndsey Gonzales

Strategic, analytical Clinical Research Leader with 20+ years of experience bridging clinical science, industry, global market operations, and cross-functional leadership perfect for the Competitive Intelligence field. Exceptional adaptability in fast-paced, matrixed environments with a proven ability to translate complex medical data, glean current market trends using KOL engagement and real-world evidence (RWE) into actionable strategic deliverables for executive stakeholders. Proven experience in cross-collaboration with physician leaders, as well as pharmaceutical, biotech and academic clients to meet deliverable goals.

Skilled in people management and leadership, team development, and giving high-impact presentations that drive business decisions, mitigate risk, and position organizations for commercial success.

Sr. Director Quality and Development at Audubon Bioscience Co. (2025-04 – Present)

• Regularly prepare and engage in high-impact discussions with senior executive teams, external sponsors, and pharmaceutical clients, translating complex global quality metrics and operational findings into strategic business deliverables.
• Managed strategic communications with external sponsors and clients regarding complex quality issues, giving detailed presentations on quality metrics, conducting intense investigations into data integrity, providing guidance to external sponsors on potential causes for technical issues and scientific outcomes, and preserving key commercial partnerships.
• Authored and revised core SOPs and policies aligned with international quality management standards, GCP, and federal regulations, providing expert guidance to operational teams on site management and documentation.
• Created standardized onboarding and competency assessment training programs, ensuring staff and site compliance with international quality standards across all active regions.
• Directed international Quality Department operations for multi-center biospecimen procurement studies across 7 countries (US, Bulgaria, Turkey, Ukraine, Armenia, Georgia, and Vietnam), embedding global GCP compliance, regulatory alignment, risk assessment and CAPA execution across all study protocols, transitioning the organization from non-compliance to protocol adherence and standardized site management practices.
• Served as the primary quality liaison during sponsor qualification audits, successfully positioning the organization as an approved global supplier; conducted internal and site-level source data audits to identify root causes and uphold continuous inspection readiness.
• Led a critical external sponsor audit within 10 days of hire, successfully salvaging a high-risk client relationship from "Not Approved" status to "Conditionally Approved" as a qualified global supplier.

Sr. Manager Operations- Rheumatology and Biorepository at CorEvitas, LLC, part of ThermoFisher Scientific (2022-06 – 2025-03)

• Collaborated directly with epidemiologists and data scientists to evaluate longitudinal RWE and produce strategic data deliverables for pharmaceutical partners navigating competitive market landscapes.
• Led direct communication with KOLs on the pharmaceutical market, engaging specialist physicians and academic researchers to ensure real-world protocol alignment with expected sponsor deliverables.
• Exercised direct people management leadership over a high-performing team, driving operational alignment and on-time project execution.
• Prepared synthesized analytical performance reports and presented findings to executive stakeholders, translating raw data into clear business and operational intelligence.
• Served as Department Lead for a major EDC migration involving multi-disciplinary teams, successfully transitioning 25+ years of longitudinal RWE data into a modernized enterprise system with zero operational disruption.
• Spearheaded targeted leadership initiatives and automated metric reporting, improving study discrepancies by 90%, enhancing adverse event documentation accuracy by 15%, and cutting sample reconciliation issues by 50%.
• Authored and reviewed key regulatory and clinical trial documents, including study protocols, Informed Consent Forms (ICFs), SOPs, and Work Instructions (WIs).

Supervisor-Biospecimen Operations and Core Research Laboratory at Department of Research, Ochsner Medical Center (2018-03 – 2022-06)

• Exercised people management leadership by scaling the departmental footprint from 3 to 15 personnel, fostering an environment of accountability and continuous professional development.
• Maintained direct communication with physicians, health system leadership, and sponsor/client partners to establish clinical research workflows and secure buy-in across multidisciplinary departments.
• Spearheaded financial management—including cost modeling, invoicing, expense control, and vendor negotiations—quadrupling department revenue within 4 years.
• Delivered quarterly business updates and financial forecasts to senior executives, using data-driven presentations to justify expansion and negotiate vendor contracts.
• Served as Principal Investigator for multiple clinical protocols and >100 biospecimen projects, designing study protocols, Informed Consent Forms (ICFs), and patient-facing materials.
• Functioned as the direct liaison with leading CROs, pharmaceutical, and biotech partners, managing end-to-end study start-up, contract and budget negotiations, execution, and close-out activities.
• Authored and enforced SOPs to centralize institutional clinical research and laboratory practices in full compliance with GCP, FDA guidelines, and institutional policies.

Postdoctoral Fellow/Laboratory Manager at Dept. of Microbiology, Immunology & Parasitology, LSU Health Sciences Center (2012-02 – 2018-03)

• Authored and edited peer-reviewed manuscripts; regularly gave scientific presentations at conferences and academic symposia to communicate ground-breaking mucosal immunology research.
• Managed and mentored multidisciplinary teams comprising physicians, graduate students, and laboratory technicians, demonstrating project management skills in balancing deliverables required for study execution.
• Led execution of human subject clinical studies focused on mucosal immunology, HIV acquisition risk factors, and hormone modulation in female reproductive health.
• Designed and executed graduate and undergraduate curricula, delivering didactic instruction, laboratory training, and participated in mentorship programs.

Doctor of Philosophy (PhD) in Immunology and Infectious Disease – Louisiana State University Health Sciences Center (2004 – 2011)

Bachelors of Science (BS) in Biological Sciences – Louisiana State University (2000 – 2004)