Alverina Pydynkowski Email & Phone Number

Boston, Ma, Us

Cambridge, Massachusetts, Us

•Coordinate clinical sample reconciliation, shipments, data analysis, clinical data transfers, and data review.• Oversee clinical study timelines and deliverables related to pharmacodynamic and exploratory biomarker analyses.• Author and review clinical study documents and biomarker vendor contracts related to the collection, processing,shipment, and storage of clinical biomarker samples.• Work with Translational Medicine and Clinical Operations team management during annual clinical budget generation andcontribute to quarterly forecast efforts related to managed clinical CROs.• Initiate and host monthly vendor management meetings to ensure oversight of contracted projects and deliverables.• Support the identification/implementation of commercially available sample management tools to bolster Blueprint’sclinical data reconciliation and integration efforts

•Author and review sample collection and analysis sections of clinical protocols, lab manuals, and study reports.•Identify commercial and academic collaborators to support biomarker assay development and execution in clinic.•Oversee translational medicine contracting lifecycle via SOW negotiation and execution, legal review, PO generation, and financial accrual tracking until a project is complete.•Implement biomarker testing plans by providing technical guidance on sample collection kit building, enabling direct vendor shipments for prospective analysis, and manually selecting samples for retrospective testing submission.•Establish data transfer agreements and specifications with external vendors alongside data management.•Maintain an internal testing and logistics tracker that captures the full lifecycle of a sample from collection through data delivery from assay vendors.•Manage all contracted translational vendors to ensure adherence to negotiated timelines and deliverables.•Present biomarker portions of the clinical protocol to clinical sites during initiation and study startup and provide ongoing technical support as it relates to biomarker sample collections.•Train new members of the translational operations team to support functional development.

• Manage clinical sample inventory and biomarker data both internally and through contracted external databases.• Negotiate and manage contracts for biomarker sample testing with commercial vendors and academic collaborators.• Support draft and review of biomarker sections of clinical protocols, lab manuals and study reports.• Work with clinical operations to establish, implement, and improve sample logistics across the clinical portfolio.• Provide technical guidance in sample collection kit building.• Identify and manage clinical sample vendors in support of biomarker assay development.

Cambridge, Massachusetts, Us

Cambridge, Massachusetts, Us

•Develop, optimize, and determine performance of T-Cell assays for use in Personalized Cancer Vaccine clinical trial.•Measure responses to personalized cancer vaccine in clinical patient samples with T-cell based immunogenicity assays.•Draft and edit detailed laboratory protocols for external use by clinical sites and clinical research organizations.•Oversee personalized cancer vaccine clinical sample storage to ensure compliance with clinical protocols.•Negotiate and establish pricing structure and delivery of clinical assay reagents with external vendors.•Support the training and implementation of PBMC processing and isolation protocols at clinical sites

Boston, Ma, Us

• Analyze Massachusetts PRAMS (Prenatal Risk Assessment Monitoring System) Data to identify disparities in postpartum depression prevalence and risk among minority populations using SAS and SUDAAN• Answer research questions to inform MA legislature recommendations

•Measure clinical immune responses via ELISpot and ELISA to support the progress of Genocea’s Herpes simplex, Streptococcus pneumoniae, and Immuno-oncology programs.•Perform animal vaccination and tissue collection in mice.•Conduct high-throughput screening on human T-Cells to identify antigen targets for future vaccine development.

•Populate a Potency Data Repository for each In Vivo Potency program presently in house.•Support Research projects by performing experimental methods including cell culture, ELISpot, and ELISA assays.

Boston, Ma, Us

• Scheduling, receiving and/or registering patients, visitors and staff for admissions, appointments or procedures.• Collecting, verifying and recording required information, obtaining records, files and/or results forappointments/admissions.• Entering related information on hospital and departmental computer systems.• Answering, screening and routing telephone calls and performing general office support tasks such as opening andsorting mail, ordering supplies and maintaining logs and records.

Master Of Public Health (M.P.H.), Epidemiology And Biostatistics

Bachelor Of Science (Bs), Biology, Health Professions

Other; Hmx Fundamentals Or (Hmx Pro) Online Certificate Program - Immunology