Eva Pekle
Principal Scientist @Apellis Pharmaceuticals
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WORK HISTORY
Principal Scientist @Apellis Pharmaceuticals
Lead outsourced clinical pharmacodynamic (PD) biomarker bioanalysis across Phase clinical trials- Manage bioanalytical method development, qualification, and validation across multiple matrices and specialty laboratories- Oversee clinical sample lifecycle, including shipment, analysis, data transfer, and reporting to support database locks and regulatory submissions- Serve as subject matter expert (SME) for PD biomarkers across cross-functional clinical programs- Manage CRO and specialty laboratory relationships, ensuring delivery against timelines, budgets, and quality expectations- Oversee quality events, including deviations, CAPAs, and notes-to-file related to external laboratories- Support GxP compliance and audit readiness, ensuring relevant documents are filed in the eTMF- Collaborate cross-functionally with Clinical Operations, Data Management and Quality.
EDUCATION
The Johns Hopkins University
Neuroscience
University of Kent
Doctor of Philosophy (PhD), Biochemistry
University of South Carolina
Chemistry
UCL
Msc. Experimental Pharmacology and Therapeutics, Pharmacology
ABOUT EVA PEKLE
I have 6+ years of experience supporting clinical bioanalysis across Phase clinical trials, working within both cell and gene therapy start-ups and large pharma. My therapeutic area experience includes ophthalmology, nephrology, haematology, and neurology, supporting global clinical development programs. I bring extensive experience in clinical trial PD/ADA data delivery, leading both in-house and outsourced bioanalytical activities, including biomarker analysis, sample management, and bioanalytical assay oversight across multiple biological matrices. I consistently deliver high-quality data aligned with clinical timelines, supporting database locks, regulatory submissions, and study milestones. My technical expertise includes bioanalytical assay development and validation, with a focus on complement protein biomarkers, ADA assays, and flow cytometry to support clinical studies. I am experienced in managing CRO partnerships, troubleshooting assay performance, and ensuring compliance with GxP, and regulatory expectations.
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