Alexis Mobley, Ms, Phd Email and Phone Number
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• Highly skilled, detail-oriented neuroimmunologist with a consistent track record of completing complex regulatory submissions, developing regulatory and clinical strategies, and cultivating learning cultures.• Adept at process improvement and tool integration, shortening project timelines, and increasing team communication.• Known as a human library, based on thorough competitive intelligence reports that lead to end-to-end strategic product development improvements, including clinical protocols and labeling initiatives.• Dynamic leadership style that elevates early career professionals and encourages teams to embrace ambiguous, complex problems leading to innovative treatments for patients.• Currently expanding interests in fit-for-purpose real-world data/evidence use for regulatory approvals and integration with artificial intelligence/machine learning platforms.
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Scientific Writing SpecialistMagnitHouston, Tx, Us -
Global Regulatory Affairs AssociateJohnson & Johnson Innovative Medicine May 2022 - May 2024Raritan, New Jersey, United StatesImmunology:Developed our pediatric investigational/study plans (PIP/PSP, respectively)Created a tracking tool to easily convert PIPs (EU) to PSPs (US) for submissionLed our early target labeling for future rheumatic indications using advanced competitive labeling intelligence and cross-functional label working group meetingsUpdated and generated our regulatory strategy documents to continue to guide drug development and regulatory submissionsGlobal Regulatory Policy and Intelligence:Advanced fit-for-purpose real-world data/evidence (RWD/E) acceptance, pediatric drug development, clinical trial diversity, and our understanding of rare diseases and orphan drug development through case study collection and trend analysisParticipated in draft guidance commenting exercises (for both the FDA and ICH) in collaboration with internal Janssen functional areas and external trade associations to develop our letters to submit to the FDA and ICH for considerationCollaborated regularly with GRA therapeutic areas epidemiology, pharmacology, pediatric/neonatal/pregnancy/lactation, and data science groupsAttended a broad range of public and private meetings hosted by global regulatory authorities and wrote regulatory policy communications to be disseminated within the company. Developed and influenced global and regional Janssen policy positions and drove acceptance towards our regional policy advocacy stances. Continue to support harmonization of RWD/RWE internally and externally through our RWE HubOncology:Supporting early and late drug development for mNSCLC (including IND submissions and sBLAs) and driving regulatory strategy for our multiple myeloma program (including specialized regulatory pathways). Lifecycle maintenance of our INDsLabeling supporting our cell and gene therapy products including Carvykti. Developed the EUPI for marketing applications for new drug formulation Led SME label working groups to align on labeling language to bring to larger team -
President And Interim Treasurer, Co-FounderBlack In Immuno Sep 2020 - Apr 2024Social media manager and content creatorLogistical team for Black In Immuno WeekWorking on filing non-profit paperwork to establish the organization as a 501(c)3 -
Graduate Research AssistantThe University Of Texas Md Anderson Cancer Center Uthealth Graduate School Of Biomedical Sciences Aug 2016 - Apr 2022Houston, Texas AreaAnalyzing the role of lymphoid cells during stroke and agingPolarizing neutrophils during development to be used as a cellular immunotherapeutic in intracerebral hemorrhageAssisted in neonatal rodent stroke model development, surgeries, sample processing, and data analysis of T-cell populations and cytokine expressionValidated experimental results of T-cell infiltration in neuronal structures after cisplatin treatment -
Graduate Student Research AssistantTexas Tech University Health Sciences Center 2015 - 2016Abilene, Texas AreaDeveloped labeled and label-free antibody specificity assays in conjunction with Resonant Sensors, Inc and ExperimmuneAnalyzed cytokine secretion from activated engineered T-cell receptor expressing cell linesCultured hybridoma, breast cancer, and engineered T-cell receptor expressing cell lines -
Graduate Student Research AssistantExperimmune Jun 2015 - Aug 2015Abilene, Texas AreaCultured breast cancer cell lines for flow cytometric analysis assaysProduced bispecific antibodies using PCR techniques to engage and activate T-cells and bind peptide-MHCConjugated protein toxins and small molecule drugs to T-cell receptor-like antibodies and validated their binding and killing capacity using flow cytometry and MTS assays
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Tutor And MentorAngelo State University 2012 - 2014Tutored lower and upper level math, chemistry, and biology classesTutored lower level physics and computer science classesMentored Freshmen and Sophomore STEM majors -
Laboratory TechnicianAngelo State University 2012 - 2013Analyzed and optimized sequencing and gel electrophoresis protocolsPrepared reagents and materials for molecular and cell biology lab coursesCultured bacterial cells and sequenced PCR productsExtracted nucleic acids from various organisms vertebrate and invertebrate organisms -
Fountain/CarhopSonic Drive-In 2009 - 2014San Angelo, Texas AreaReceived and completed food, drink, and ice cream ordersDelegated tasks to other crew membersResolved customer issues and maintained customer satisfactionOptimized time during high traffic situations -
RunnerRatliff And Edwards Law Offices 2011 - 2012San Angelo, Texas AreaDelivered documents to law firms and government officesInput new client information and archive previous client filesStocked and ordered new office suppliesMaintained and input payroll and leave approval documents
Alexis Mobley, Ms, Phd Skills
Alexis Mobley, Ms, Phd Education Details
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Neuroscience And Immunology -
Texas Tech University Health Sciences Center Graduate School Of Biomedical Sciences - AbileneBiotechnology -
Magna Cum Laude
Frequently Asked Questions about Alexis Mobley, Ms, Phd
What company does Alexis Mobley, Ms, Phd work for?
Alexis Mobley, Ms, Phd works for Magnit
What is Alexis Mobley, Ms, Phd's role at the current company?
Alexis Mobley, Ms, Phd's current role is Scientific Writing Specialist.
What is Alexis Mobley, Ms, Phd's email address?
Alexis Mobley, Ms, Phd's email address is am****@****elo.edu
What schools did Alexis Mobley, Ms, Phd attend?
Alexis Mobley, Ms, Phd attended The University Of Texas Md Anderson Cancer Center Uthealth Graduate School Of Biomedical Sciences, Texas Tech University Health Sciences Center Graduate School Of Biomedical Sciences - Abilene, Angelo State University.
What are some of Alexis Mobley, Ms, Phd's interests?
Alexis Mobley, Ms, Phd has interest in Science And Technology, Education, Health.
What skills is Alexis Mobley, Ms, Phd known for?
Alexis Mobley, Ms, Phd has skills like Biotechnology, Assay Development, Tumor Immunology, Cancer Immunotherapy, Biochemistry, Immunology, Research, Leadership, Microsoft Office, Customer Service, Microsoft Excel, Management.
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