Mario Brown
Summary
Clinical research professional with over 25 years research experience at global level. Proven leader able to provide functional, program, study and direct line management and oversight activities related to the execution of clinical trials. Successful track record of leading execution and implementation of global process and program initiatives from start to finish; Successful track record of delivering on business imperatives. Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success.
Overview
25
25
years of professional experience
Work History
Director Clinical Site Operations
Pfizer
09.2019 - Current
- Oversee tactical implementation of the clinical development plan by managing the timeline, resources and budget of clinical studies
- This role also manages the Quality Oversight and supervises the compliance oversight activities to ensure patient safety and quality of study execution in accordance with applicable prevailing laws, Good Clinical Practice, and Pfizer standards
- Liaise with Contract Research Organizations (CROs) and third-party vendors to ensure study execution and deliverables are being met
- The Director of Clinical Operations represents Global Product Development (GPD) as the point of contact for country/regional teams
- This role drives the end-to-end connection of country/cluster stakeholders across a portfolio and collaborates with other stakeholders at the global level to ensure country input into the clinical development and country strategy
- This role is also responsible for communication of the future trial portfolio to appropriate country/cluster stakeholders
- The Director of Clinical Operations leads initiatives that support the clinical development environment within their region in order to facilitate Pfizer's clinical development goals and scientific leadership
- Developed, implemented, revised, and evaluated policies and procedures.
- The Director of Clinical Operations provides insights on local/regional trends to facilitate the conduct of clinical trials and where appropriate is responsible for developing analyses and offering options for mitigation (both at the study and site level) on the trial's conduct
- Business Unit Head for designated asset responsible for all site facing operational aspects of trial delivery.
Director of Operations
PAREXEL International
05.2019 - 07.2019
- (Realigned position - no longer available)
- Responsible for the oversight of all operational aspects of the clinical trials within Parexel for Biotech Division and largest Sponsor
- Serve as the clinical strategy leader to assigned portfolio (including oversight of cross-functional subject matter experts, business process owners and clinical management staff)
- Ensure operational imperatives of the clinical strategies and the trial designs are aligned to ensure efficient and effective use of company resources
- Meets regularly with Managers/Directors to discuss issue escalations on active studies
- Manages all activities and staffing issues related to Early Phase - Late Phase IV clinical trials including hiring, training, scheduling, coaching/counseling, evaluating performance and terminating staff
- Interfaces with key departments to discuss status of current studies
- Establishes and maintains relationships with clients, vendors, and hospital representatives
- Oversaw successful implementation of operational strategies and policies to drive organizational growth and productivity.
Director, Clinical Operations
Aeglea Biotherapeutics
08.2018 - 05.2019
- Responsible for the oversight of all operational aspects (project management, monitoring, vendor management, finance) of the clinical trials within Aeglea
- Accountable for the development of project specific operational strategy and tactics regarding the implementation of clinical programs
- Provides direction and accountable for the management and oversight of external partners, consultants, vendors and budgets to ensure the timely and cost-effective implementation of CDPs
- Provide direction in setting priorities and implementation of functional assignments, policies and procedures to ensure quality, meet milestones that alight with company and department priorities
- Provide leadership, line management and quality oversight of monitoring, project management and operational team
- Worked closely with organizational leadership and board of directors to guide operational strategy.
Associate Director, North America Clinical Ops
Novo Nordisk
04.2011 - 08.2018
- Assisted senior leadership in managing all aspects of operations.
- Operational management of entire western half of US (and Canada)
- Directly responsible for functional operating budget and resource allocation management
- Operational coordination and communication between regions within territory
- Provide leadership to team of Senior Managers, Managers across assigned territory
Regional Area Manager
Allergan, Inc
03.2003 - 04.2011
- Provide leadership, supervision and quality oversight of monitoring team
- Management and development of regional staff and resource planning relating to the administration of clinical trials
- Direct supervision of regional CRAs (14-17), including training, development, hiring, discipline, and termination
- Conduct performance appraisals and provides guidance and assistance in goal and objective setting with employees
- Assist in assessment and allocation of resources for department and for respective regional group
- Assists with department planning and operations, including department meetings
- Ensure adequate dissemination of information to relevant staff relating to departmental issues, personnel, and study conduct
- Perform training for CRAs and train staff to various new procedures and/or technologies
- Cultivated culture of open communication, collaboration and shared accountability for business success.
Regional Senior CRA
Contracted
04.2003 - 08.2003
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Monitor clinical research projects to ensure adherence to sponsor protocol, data integrity and regulatory compliance.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
Project Manager
PPD, Inc
03.2002 - 04.2003
- Performed any or all project management functions
- Supervision of the project team and clinical team of CRAs (12-14)
- Serve as Line Manager for project team of CRAs (12-14)
- Communicated with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues
- Generation and tracking of Investigator and site payments according to contract/client budget
- Communicated with client regarding study issues.
- Monitored project performance to identify areas of improvement and make adjustments.
- Provided detailed project status updates to stakeholders and executive management.
Senior Clinical Research Associate
Parexel International
09.1998 - 03.2002
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Exercised a leadership role for project activities related to monitoring functions, design of study tools, tracked flow of clinical data at investigational sites, kept ongoing records of status of sites and patients
Education
Master of Science - Forensic Science
National University
La Jolla, CABachelor of Science - Biology
St. Edward's University
AustinSkills
- Demonstrated project management/clinical operations experience and leadership skills (eg, managing cross functional teams, CROs, vendors)
- Extensive experience with clinical compliance and SOP development; Subject matter expert on various and multiple operating procedures (eg, monitoring, trial management, best practices)
- Strong communication skills (verbal and written)
- Utilization Management
- Windows XP/Vista, Microsoft Office, WordPerfect, PowerPoint and Excel
- Experienced in various CTMS systems including Impact, Impact Business Object Reports, My Sites and Siebel; Experienced in various e CRF systems including Inform, MediData and Data Track
- Experienced in various e Learning Management Systems including Captivate and Articulate
- Experienced in SharePoint management systems as well as electronic document management systems (First Doc and Documentum)
- Experienced in various Site Start Up electronic systems (ie, Activate Go Balto, Shared Investigator Platform)
- Collaborative Skills
- Staff Development
Accomplishments
- Achieved successful trial delivery by introducing and directly supporting team "hands on" working in a "lightspeed" fashion
- Devised effective procedures and protocols resulting in 100% compliance with audit requirements.
- Directly supervised team of > 30 staff members.
Affiliations
Association of Clinical Research Professionals (ACRP) Drug Information Associate (DIA)
Society of Clinical Research Sites (SCRS)
American Association of Forensic Science Professionals
Languages
English
Native or Bilingual
Spanish
Professional Working
German
Limited Working
Timeline
Director Clinical Site Operations
Pfizer
09.2019 - Current
Director of Operations
PAREXEL International
05.2019 - 07.2019
Director, Clinical Operations
Aeglea Biotherapeutics
08.2018 - 05.2019
Associate Director, North America Clinical Ops
Novo Nordisk
04.2011 - 08.2018
Regional Senior CRA
Contracted
04.2003 - 08.2003
Regional Area Manager
Allergan, Inc
03.2003 - 04.2011
Project Manager
PPD, Inc
03.2002 - 04.2003
Senior Clinical Research Associate
Parexel International
09.1998 - 03.2002
Master of Science - Forensic Science
National University
Bachelor of Science - Biology
St. Edward's University
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