Alexes Gonzalez
Seattle,WA
Summary
Seasoned clinical trial scientist with a Masters in Drug Development and Product Management. 8 Years of experience in dermatology and passionate health care professional. Proficient in current drug development regulations, standards, and best practices. Analytical and detail-oriented professional focused on making sure products meet all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Specialist
Solta Medical Inc.
10.2022 - Current
- Assisted with regulatory product compliance initiatives such as: Letters of authorization, adverse event report, dossier preparation for medical device registration, label change assessment, submission to 32 global health authority agencies, liaise with key stakeholders by acting as primary point of contact.
- Manage global vendor and third party contracted agreements. (CRO selection, feasibility assessment, vendor budget plan, Etc).
- Develop a Phase IV clinical trial to obtain substantial evidence to support a clinical claim for a medical device 510(k) section submission (Indication of use and safety assessment claim).
- Serve as subject matter expert and clinical scientist for 6 medical devices for clinical dermatology with a proven track of expertise with real world evidence, providing support to multiple stakeholders.
Sr. Clinical Research Coordinator
Cosmetic Laser Dermatology
06.2019 - 10.2022
- Design and develop 6 Phase IV clinical trial protocols including clinical research forms, Informed Consent Forms, TMF, Investigatory Brochure sections and CRF's.
- Serve as a lead clinical coordinator for 35 clinical trials ranging from Phase I to Phase IV, ensuring data integrity, adherence to ICH GCP requirements, clinical data query and resolution (Including Atopic Dermatitis, Basal Cell Carcinoma, Actinic Keratosis, Venous Insufficiency trials using monoclonal antibody and energy based treatments as Investigational Product).
- Manage a clinical research department by negotiating CTA's with sponsors and CRO's, train jr staff coordinators and dermatology fellows, and submit clinical trial reports to local IRB, FDA, CRO's and clinicaltrials.gov.
- Serve as a lead clinical scientist by presenting clinical trial data and substantial findings for investigator initiated trials and grants leading to 2 clinical trial publications in high impact medical journals.
- Liaise with KOL's in a matrix oriented team by presenting key metrics, deliverables, milestones and risk mitigation.
Pharmacist
TJ plast Advanced Plastic Surgery Center
10.2017 - 10.2018
- Review and report adverse events for an outpatient clinic
- Support development and operations of a Phase IV trial with 450 patient involvement leading to NDA submission in Mexican Health Authorities
- Create milestone spreadsheets and clinical schedule of events in order to track data from visits, A/E's, PI reviews and source documentation
- Develop Informed Consent Form for clinical trial participation.
Education
Master of Science - Drug Development And Product Management
University of California San Diego
San Diego, CA06.2022
Diploma in Clinical Research -
Clinical Research Fastrack
Scottsdale, Arizona01.2020
Bachelor of Science in Biology and Pharmacology Chemistry -
Autonomous University of Baja California
Tijuana, Mexico01.2018
Skills
- Tracked expertise in research: Published 2 clinical articles for the Journal of Drugs in Dermatology Strong experience in literature interpretation and translational research
- In depth knowledge of ICH GCP standards: Ensure TMF is audit ready and manage Good Documentation Practices by implementing ALCOA principles
- Fluent in English and Spanish
- Proficiency in drug development process, study design, clinical operations
- Collaborative teamwork: Establish relationship with key stakeholders, KOL's, Field-Physicians and clinical staff
- Vendor management: Create clinical contract agreements and budget plans, implement feasibility assessment
- Risk Mitigation: Identify potential risks by auditing the study development and schedule of event compliance Employ effective CAPA plans and resolutions as needed
Certification
Good Clinical Practice, NIDA Clinical Trials Network, 2023
Timeline
Regulatory Affairs Specialist
Solta Medical Inc.
10.2022 - Current
Sr. Clinical Research Coordinator
Cosmetic Laser Dermatology
06.2019 - 10.2022
Pharmacist
TJ plast Advanced Plastic Surgery Center
10.2017 - 10.2018
Master of Science - Drug Development And Product Management
University of California San Diego
Diploma in Clinical Research -
Clinical Research Fastrack
Bachelor of Science in Biology and Pharmacology Chemistry -
Autonomous University of Baja California
Similar Profiles
Victoria M SparkmanVictoria M Sparkman
Senior Manager, Sales Training at Solta MedicalSenior Manager, Sales Training at Solta Medical
MARC RODMANMARC RODMAN
Senior Regional Business Manager (Director) at Solta Medical, BAUSCH HEALTHSenior Regional Business Manager (Director) at Solta Medical, BAUSCH HEALTH
Lance BecoatsLance Becoats
Lead Electronic Test Technician II at Solta MedicalLead Electronic Test Technician II at Solta Medical
Angel GarciaAngel Garcia
Deli Clerk at SafewayDeli Clerk at Safeway
Gabriel FuquaGabriel Fuqua
Lead Bartender at PajuLead Bartender at Paju