Alejandro Urgelles
Conroe,TX
Summary
With a decade of industry experience, my expertise spans Oncology, Neurosciences, Rare Diseases, and Immunology, complemented by a profound knowledge in MSCs, CAR-T, TAC-T, and MAb therapies. I'm adept in cGMP, ICH, GCP standards, and excel in Clinical Development/Operations, including CDPs, INDs, CSRs, and Clinical Trials design. My additional interests lie in Neurodegeneration, Immunotherapies, Drug Discovery, and Epigenetics. I hold a Doctor of Medicine degree from Cuba's National Board of Medical Examiners (2013) and a Certificate in Immuno-oncology from Harvard Medical School (2024).
Outside of work, I'm happiest surrounded by big trees in the woods, exploring trails or just taking in the scenery with my two dogs and any friend who tags along. These moments of connection with nature not only refresh me but also fuel my creativity and passion for my career in the biomedical field.
Overview
7
7
years of professional experience
Work History
Sr. Clinical Scientist
Triumvira Immunologics
08.2023 - 02.2024
- Worked with medical directors, clinical operations, biostatistics and other groups to conduct clinical reviews of study data.
- Led protocol development, meticulously reviewed, and monitored incoming data, promptly identifying, and reporting trends such as adverse events (AEs), serious adverse events (SAEs), and positivity to cancer biomarkers (Claudin18.2 and HER2) while also crafting abstracts, designing posters, and delivering presentations at stakeholder meetings and annual conferences (ASCO GI, SITC).
- Worked with clinical teams on study site visits and protocol training.
- Worked with clinical operations and medical directors to develop consistent language and criteria for forms, protocols, reports and safety procedures.
- Reviewed patient eligibility criteria meticulously prior to leukapheresis procedures and dosing, ensuring compliance with study protocols.
Senior Clinical Trial Lead
CARsgen Therapeutics
11.2021 - 08.2023
- Reviewed patient eligibility criteria meticulously prior to leukapheresis procedures and dosing, ensuring compliance with study protocols, and patient safety.
- Executed preclinical and clinical study protocols, assessing therapies' efficacy and safety.
- Analyzed and interpreted data related to patient safety (CRS/ICANs and other AEs’ occurrences and management)
- Analyzed and interpreted efficacy data (CT/PET Scans, RECIST 1.1 readings, PK, and tumor biomarkers) to identify trends, outcomes, and effectively presented to Medical Director and CMO.
- Attended national oncology conferences and reviewed literature to augment expertise in our specific therapeutic area.
- Monitored unit budget to meet financial objectives for spend rate and funding.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Identified issues, analyzed information and provided solutions to problems.
Clinical Scientist and Medical Affairs Specialist
Hope Biosciences
07.2017 - 06.2020
- Assisted with completion and submission of regulatory filings and other regulatory documentation.
- Worked with clinical teams on study site visits and protocol training.
- Led clinical trial protocol development and prepared amendments.
- Designed and executed preclinical and clinical study protocols, exploring new therapies' efficacy and safety.
- Collaborated in the creation of clinical development plans, product lifecycle plans, and drafted labels.
- Lead the creation and validation of eCRFs for all clinical trials assigned, and associated training documents and review data completeness and fidelity throughout study conduct.
- Conducted data analysis and interpretation, identifying trends, efficacy outcomes, and adverse events. SAE reconciliation.
- Collaborated with the planning and writing of periodic safety reports
Education
Professional Certificate - Immunoncology
Harvard Medical School
02.2024
Master of Science - Health Administration
West Coast University
Dallas, United States04.2022
M.D. - Medicine
Medical University of Holguin
Holguin, Cuba07.2013
Skills
- Stakeholder Communication
- Scientific Writing
- Drug development
- Training and mentoring
- Signal detection
- Interdisciplinary Collaboration
- Medical terminology knowledge
Languages
Spanish
Native or Bilingual
English
Native or Bilingual
Italian
Limited Working
Timeline
Sr. Clinical Scientist
Triumvira Immunologics
08.2023 - 02.2024
Senior Clinical Trial Lead
CARsgen Therapeutics
11.2021 - 08.2023
Clinical Scientist and Medical Affairs Specialist
Hope Biosciences
07.2017 - 06.2020
Professional Certificate - Immunoncology
Harvard Medical School
Master of Science - Health Administration
West Coast University
M.D. - Medicine
Medical University of Holguin
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