Accountable for leadership of the clinical country and site operations for all global regions (North America, Europe, and Biogen Intercontinental region), supporting all Biogen Development clinical trials across all phases and therapeutic areas. Responsible for guiding the team of regionally based clinical country and site leads, strategic guidance for global program CCSL roles, providing leadership and direction through a management team of Regional Heads, CCSM-Medical site engagement, and Program lead CCSLs for critical programs and indirectly through sub-regional heads across Europe and BIR. Additionally, part of the Global Clinical Operations LT supporting multiple workstreams on trial delivery, acceleration, and Clinical Trial Diversity team therein to ensure health equity and under-represented patient population goals are met in the US, and regional diversity programs are deployed, which includes developing new partnerships with investigative sites in new geographies (incl metro areas). Partner closely with the regional affiliate leaders and regional medical leads to ensure regional business needs are appropriately reflected in country selection strategy for clinical trials in the pipeline and apply commercial awareness to develop operating plans and drive performance across the regions. Work closely with CRO partners to ensure operational excellence in executing clinical trials, including site performance across all regions. Accountable for resource (budget and headcount) management for the Country & Site Operations organization, development of their staff, and leading an organization of continuous improvement.

Member of the leadership team for Global Clinical Operations representing the site engagement for the US region, which encompasses all sub-regions of the US and Puerto Rico and represents the largest region by clinical trial volume for the Biogen portfolio. As CCSM Regional Head provides guidance, leadership, and direction through a management team and is accountable for the performance of the CCSM function in the US for all Biogen clinical trials across all phases of development and all therapeutic areas. Partners with multiple stakeholders (Patient Engagement and Health Equity, Regional President, Medical regional and global commercial stakeholders. Accountable for resource (budget and headcount) management for the collective CCSM organization, development of their staff, and leading an organization of continuous improvement.

Responsible for leading a team of Clinical Project Management Portfolio Heads, Project Oversight, and Line Managers of Project Managers across Infection Disease, Respiratory, and Rare Diseases. Support clinical operations strategy and management of global clinical programs by overseeing staff, resourcing, training, and allocating resources to projects. Oversee the execution of studies in a matrix management structure to ensure compliance with quality standards (including ICH GCP, local regulations, and appropriate SOPs). Mentor new staff and oversee coaching of new hires in navigating career progression options. Clinical trial project and program delivery, ensuring metrics and goals are achieved according to the Drug Development Plan, managing resources, and implementing ongoing learnings sharing best practices across studies.

 Project and program oversight of a portfolio of clinical trials from Early Clinical Development (Phase I healthy volunteers) to Phase III in the Central Nervous System, ensuring clinical trials are delivered per the Drug Development Plan and with quality.  Responsible for overseeing key clinical operations areas within the portfolio like Data Technology, eTMF, Vendor Management, and Early Strategic Drug Development Plan planning.  Work in collaboration with Quality Management and Quality Assurance to implement activities. Responsible for crucial stakeholder management across multiple organizations to ensure proper clinical project delivery.  Responsible for ensuring consistency of work, monitoring delivery & and process, and supporting continuous improvement of work Chair/Co-chair Operational Governance Committee/serve on sub-committees. Solely responsible for the resolution of operational escalation, both internal and external.

 Direct and manage an assigned team of Therapeutic Strategy Leads responsible for developing project therapeutic and executing clinical operation strategies across different therapeutic areas (Oncology, Cardiovascular, CNS, Rare Disease, and Infection Disease) and study phases (Early Clinical Phase to Phase IV). Actively guide the leads to ensure tailor-made strategies (patient pathway, clinical operations execution, market data, competitive landscape, enrolment projections, and trial completion) to accomplish the drug development plan timelines, ensuring quality and speed. Responsible for implementing department mission, goals, objectives, oversight of operations, and development of department policies, procedures, and standards. Facilitates strategic scientific and operational input, maintenance, and continued evaluation of clinical development plans across programs

 As a Global Therapeutic Strategy Lead Director (Cardiovascular, Respiratory, and Infection Disease), I was responsible for understanding each clinical development plan's needs, incorporating clinical project management, Medical Group, Data Management, Bios, and finance evaluation to find the right strategy to a thriving global clinical trial execution (operationally and financially) for all distinct phases (I to IV). Responsible for leading the right strategy and support delivery of global and mega-trials in Cardiology, Infection Disease, and Respiratory. Early planning strategy development, including recruitment scenarios, optimization of country and site according to DDP requirements, market evaluation, and competitive study landscape assessment on top of cost and metrics. Ongoing support for global programs to refine cycle times, recruitment, and study conduction based on moving competitive landscape; advise on execution strategy, recruitment strategies, retention, and overall study management support

Brazilian CRO association - president

Board Director of Brazilian CRO association

 Site Head – responsible for Brazilian affiliate overseeing the operations for all groups represented in the country (Clinical Monitoring Management, Project Management, Regulatory and Start-up, Pharmacovigilance, Investigator Contracts) on the top of management of the company according to local laws and requirements.  Director of Clinical Trial Management - Direct responsible for Global and Regional Clinical Trial Managers/Directors in Americas (the US and LATAM) overseeing a portfolio of trials from Phase I to Phase III in CNS, Oncology, and Cardiovascular. Responsible for managing the group in line with projects and company goals. Business and Development support in Defense Meetings, commercial strategy, analysis, and sign-off in proposals/scope of work, promoting quality and consistency in RFPs aligning with clients’ needs.

 Regional Operational Head– Operational oversight of one key account of a portfolio of 14 regional studies, including Projects Manager and Therapeutic Leads across Respiratory and Oncology; Total team of 65 people. Responsible for oversight of metrics, client relationship management, governance meetings, and broad support internally and externally to ensure a successful project delivery Line Management responsibilities - Responsible for a team of Trials Leads and Project Managers, to ensure that staff is meeting defined workload, quality, and budget metrics through regular review and reporting of findings as outlined by clinical operations management, participates in corporate or departmental quality or process improvement initiatives.

 Creation and implementation of Site ID department in Latin America with a team based in Argentina, Brazil, Chile, Colombia, Costa Rica, Guatemala, Mexico, and Peru.  Responsible for providing capability information for all protocols coming to the region; responsible for set-up plans, timelines, present on upper management meetings, and client meetings. Regional Head for companies’ initiatives to promote the region into the Global Clinical Trial environment Regional Project Manager for Phase III Asthma study

 As Line Manager: Leading a team of Clinical Research Associates, hiring, selection and training of new clinical staff, over the sighting of training plan execution, SOP review and mentored training experiences. Also, responsible for the allocation of resources for the project, identification of quality risks/issues and creation of appropriate corrective action plans to prevent or correct deficiencies in the performance of staff. As a Regional Project Manager: Responsible for projects (since budget calculation, trough project close-out) in Respiratory and Cardiovascular (Phase III).

 Global Phase III trial in COPD and Asthma. Responsible for planning, coordination, implementation and ongoing management of clinical monitoring activities and staff. Oversee study progress and timelines.

 Project Manager for Phase I Oncology Trial and Phase II Cardiovascular Trial. Support the QA team in SOP development for the Company and Clients. Broad support to early clinical planning – CRF Form development, protocol, and ICF writing and revision to assure the ICH/GCP Compliance, project implementation, and conduction.

 Main Responsibilities: Responsible for the conduction of 4 Clinical Trials Phase II and III in Oncology. Perform all related processes which are necessary for the Clinical Trial conduction: Ethical and Regulatory Processes, Source document verification, Drug accountability, Study Files creation and maintenance, and site staff training, among other activities.

 Main Responsibilities: Responsible for the conduction of 4 Clinical Trials Phase II and III in Oncology. Perform all related processes which are necessary for the Clinical Trial conduction: Ethical and Regulatory Processes, Source document verification, Drug accountability, Study Files creation and maintenance, and site staff training, among other activities.

 Main Responsibilities: Responsible for the conduction of 1 Clinical Trials Phase III in Oncology and 2 Phase IV in CNS. Perform all related processes which are necessary for the Clinical Trial conduction: Ethical and Regulatory Processes, Source document verification, Drug accountability, Study Files creation and maintenance, and site staff training, among other activities