Chair #45: http://www.amrj.org.br/site/index.php/br/titularesInauguration speech: http://www.amrj.org.br/_pdf/discurso_pggn.pdf (p.1: Portuguese, p.8: English, p.15: Spanish).Short bio: http://www.amrj.org.br/_pdf/discurso_pggn2.pdf (p.1: Portuguese, p.15: English, p.29: Spanish).Some publications: http://www.amrj.org.br/site/index.php/br/publicacoes

Direct medical responsibility for the clinical development of a portfolio of infectious disease vaccines, leading a team of Clinical Scientists, creating overall clinical development plans, designing clinical studies, writing protocols, ensuring timely execution and medical monitoring, all in close collaboration with relevant internal and external partners (Gates Foundation, CEPI, NIH/NIAID and Gilead), Clinical Research Organizations and regulatory agencies. Strong external scientific engagement component representing Gritstone’s interest at scientific and medical conferences.

• Responsible to support VBU functions by providing strategic direction andoversight of the Clinical Development, Medical Affairs and Epidemiologyactivities in Latin America and North America, taking into consideration thelocal/regional medical, scientific, operational, regulatory and commercialmatters.• Responsible to provide the required development expertise and ability tointegrate the regional input for resourcing, overseeing and execution of theClinical Development strategy in a complex multi-disciplinary matrixorganisation.• Responsible to build regional Key Opinion Leaders (KOLs) network inpartnership with Medical Affairs.• Responsible for leading the function, develop skills of Regional Physiciansand maintain Regional Medical knowledge.

Lead and drive strategy for the overall global clinical development in the assigned area, taking into consideration the medical, scientific, regulatory and commercial issues. Lead a multi-disciplinary, multi-regional, matrix team through highly complex decisions. Decisions development assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned area in multiple regions. Apply clinical/medical decision making to clinical development issues. Influence senior leadership decision-making by setting strategic direction.

Coordinator of the first post-graduation program (sensu latu) in clinical research certified by Brazilian Ministry of Education.Some history: - http://santamemoria.org.br/prof-dr-fpedro-g-garbes-netto/- https://youtu.be/SoGLSFuu0SQ

Accountable for Medical Graduation and Post-Graduation (Internal Medicine) management. Responsible for Medical Assistance and local scientific publishing program. Consultant to Brazilian Army and several Hospitals on Infectious Diseases and Hospital Infections.

Provide regional clinical R&D support to central clinical franchises as well as to local investigators. Provide strategic and scientific input to clinical development plans and study protocols from a regional and country perspective. Assist the investigative teams with any medical questions during protocol discussions and study conduct in close collaboration with regional study management, pharmacovigilance and regulatory affairs. Support local and regional interactions with regulatory agencies, government and supranational non-governmental organizations and public health agencies as required and in close collaboration with central R&D and global medical affairs. Essential Functions/Responsibilities:• Provide regional clinical R&D support to central clinical franchises as well as to local investigators. • Act as a key local contact for investigators and will assist with critical medical issues.• Provide early strategic and scientific input into clinical development plans and the corresponding target product profile from a regional perspective.• Ensure that all clinical trial activities in the region comply with the highest quality and ethical standards. • Manage local budgets as applicable and in compliance with current budget control measures.• Act as a Clinical R&D ambassador in the region; you will serve as a key interface between central R&D, investigators and regulatory authorities in the region and external partners. • Based in the region, maintain excellent communication with the central organization as well as managing the complex interface between central and regional internal and external stakeholders.

Provided Regulatory and Clinical (Safety) support for registration of new products.

Responsible for Structuring and Developing Pharmacovigilance Dept, including PSURs management, human resources training, software development and creating an environment that matches Brazilian and other Latin America Countries Legislation.

Hospital Infections Control

Provided Clinical, Medical and Regulatory support for Botox clinical development.

Accountable for creation, implementation and delivery of large collaborative latin american clinical trials in Oncology.

Direct report into General Manager. Accountable for new business development, clinical research protocol development for phase II to IV studies, epidemiological research, ethical and regulatory interface and approvals at MoH, sites, investigators and CROs selections and management throughout Brazil. Main areas: Infectious diseases, Anesthesiology, Oncology, Intensive Care and Radiology. Also accountable for finance management. In charge of local pharmacovigilance activities for clinical trials and spontaneous adverse events. Accountable for new product development and licensing. Responsible for sales rep and managers medical training. Responsible for compliance, crisis management and government affairs.

Direct report into General Manager. Accountable for clinical research protocol development for phase II to IV studies, experimental and epidemiological research, ethical and regulatory interface and approvals at MoH, sites, investigators and CROs selections and management throughout Brazil. Main expertise areas: Infectious diseases, Oncology, Cardiology, Urology, Pneumology, endocrinology/metabolism, neuropsychiatry and intensive care. Also accountable for finance management of more than GBP 1M/year. In charge of local pharmacovigilance activities for clinical trials and spontaneous adverse events. Key contact in LOC for clinical development. Accountable for new product development and licensing in infectious diseases. Responsible for sales rep an managers medical training. Responsible for quality management (Quality Management System), compliance, crisis management and government affairs.

Responsible for developing clinical trials, phase II to IV, and experimental research, managing budgets greater than GBP1M in more than 20 trials.

Responsible for medical affairs, crisis management, medical information and govern affairs support as well as legal support.