V. Miles Rios, Jr.
Seattle,WA
Summary
Accomplished Clinical Operations and Quality Assurance Leader at Vertex Pharmaceuticals with a proven track record of enhancing study adherence, compliance, and site engagement. Expertise in personnel and financial management ensures meticulous agency inspection readiness. Strong presentation skills facilitate the cultivation of key investigator relationships, driving R&D excellence. Committed to advancing clinical research through innovative operational strategies.
Overview
38
38
years of professional experience
1
1
Certification
Work History
Associate Director
Vertex Pharmaceuticals
05.2022 - Current
- Perform R&D GCP Quality Assurance oversight and issue management activities of clinical trial operations and applicable vendors to ensure Vertex trials are conducted in accordance with GCP guidelines, applicable regulations, protocols (protocol compliance) and Vertex policies, and procedures and quality standards as set forth in the Quality Management System
Principle
Vertex Pharmaceuticals
01.2021 - 05.2022
- Regional Site Advocate (RSA)- Field-based role: Accountable for building and managing site relationships and serving as primary site advocate in assigned territory West USA/Canada, USA Mtn
- States
- This, while overseeing site-level study start-up, conduct, and close-out activities outsourced to a CRO for global programs across different therapeutic areas, including protocol adherence, Inspection/Audit preparedness and readiness
- Served and an escalation point for site staff to resolve potential operational study barriers to ensure study objectives are being met
Associate Director
EMD Serono/Merck KGaA/Darmstadt
10.2015 - 12.2020
- Site Relationship and Operations Lead (SROL)- Field-based regional role: Built and managed site relationships providing operational and scientific expertise, while overseeing site-level study start-up, conduct, and close-out activities outsourced to a CRO for global programs across different therapeutic areas, including protocol adherence, Inspection/Audit preparedness and readiness
- Provided internal teams with operational direction to assist with driving operational strategies and plans, including leveraging various site performance metrics to advise site/country/regional level decision making
- Served and an escalation point for site staff to resolve potential operational study barriers to ensure study objectives are being met
Sr. Consultant
VMR Consulting San Francisco
04.2014 - 10.2015
- Filled various management level roles Assoc
- Director, Director, Sr
- Director
- Provided clinical operations & compliance/Quality Assurance, Clinical Site Lead/Liaison leadership to various therapeutic project teams
- Medical Affairs/Clinical Operations
Director
Vivus, Inc.
02.2012 - 04.2014
- Established Neurology Med Affairs/Operations department including Ph4 and Registries, personnel management, systems development, SOP/Work Instruction development, and Quality Assurance/Compliance standards to meet audit/inspection and safe harbor requirements
- Functioned as a Clinical Operations department internal consultant
Director/Associate Director
Ipsen
02.2008 - 12.2011
- Established Neurology Medical Affairs/Operations dept
- Including Ph4 and Registries, personnel management, fiscal management, systems development, SOP/Work Instruction development, and Quality Assurance/Compliance standards to meet inspection and safe harbor requirements
- Functioned as a Clinical Operations department internal consultant
Associate Director
BioMarin Pharmaceuticals, Inc.
11.2004 - 02.2008
- Managed all aspects of Clinical Operations of multiple clinical therapeutic areas
- In addition to personnel management, fiscal management, systems development, SOP/Work Instruction development
- Functioned as the Clinical Operations and Agency Inspection Readiness Lead for the Agency approval for KUVAN
Sr. Associate
Genentech
09.1986 - 12.2004
- Clinical/Medical Operations: Managed all drug development Operations aspects across multiple therapeutic areas (such as Respiratory, Endocrinology, Immunology)
- Advanced from individual contributor to various senior management roles
- GCP Compliance: Functioned as USA GCP Compliance Auditor Included research sites, vendors, animal facilities and limited GLP laboratories
- Also performed various internal Quality Assurance and Clinical Quality Management activities such as protocol reviews, operational plans, issue mgmt
- Including QEs, Investigations, CAPAs, Effectiveness Checks
- General Management: Experienced with study planning and design, regulatory Compliance and documentation, site management and liaison, subject safety and data quality, monitoring and oversight, personnel training and support, project and fiscal management, and collaboration and reporting to Sr
- Leadership
Education
Master of Arts - Management
John F. Kennedy University
Bachelor of Science - Microbiology; Chemistry Minor; Medical Technology
California State Polytechnic University
Skills
- Clinical
- Clinical Site Lead (CSL)
- Site Engagement
- KOLs
- PAG
- Neurology
- Site Feasibility
- Medical Affairs Operations
- R&D Leadership
- Presentation Skills
- Quality Assurance
- Study Adherence & Compliance
- Investigator Site Relationship Management
- Personnel Management
- Agency Inspection Readiness & Preparedness
- Clinical Research Site and Vendor Audits
- Vendor Management
- FSP
- Financial Management
- Data Awareness
- Scientist
- Analyst Role
Certification
- CCRA
- ACRP-CCRA (Association of Clinical Research Professional)
- MRQA
- MSQA
- MASQ
Projects
Site Recruitment, 01/01/21 - 05/01/22, Assisted clinical investigators by providing tailored recruitment strategies, including patient outreach tools, staff training, and performance tracking, to enhance enrollment and streamline the recruitment process, ensuring trials meet their targets efficiently and effectively.
Awards
Avice M. Saint Graduate management Award, John F. Kennedy University, Outstanding Scholastic Achievement in Leadership: Field of Management
Recognitionawards
- Vertex Pharmaceuticals, GMDA: Gold VOCAPs, Silver VOCAPs/High-Fives
- BioMarin, Four recognition awards: Outstanding contributions to process improvement and project management
- Genentech, Inc., 18 recognition awards for outstanding contributions to project teams
Timeline
Associate Director
Vertex Pharmaceuticals
05.2022 - Current
Principle
Vertex Pharmaceuticals
01.2021 - 05.2022
Associate Director
EMD Serono/Merck KGaA/Darmstadt
10.2015 - 12.2020
Sr. Consultant
VMR Consulting San Francisco
04.2014 - 10.2015
Director
Vivus, Inc.
02.2012 - 04.2014
Director/Associate Director
Ipsen
02.2008 - 12.2011
Associate Director
BioMarin Pharmaceuticals, Inc.
11.2004 - 02.2008
Sr. Associate
Genentech
09.1986 - 12.2004
Master of Arts - Management
John F. Kennedy University
Bachelor of Science - Microbiology; Chemistry Minor; Medical Technology
California State Polytechnic University
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