Monica Reale Email & Phone Number

Barcelona, Spain

Steered optimal supervision of medical and safety clinical trials, bolstered by providing invaluable corporate support for executing business opportunities. Managed and maintained highest standards of good clinical practice (GCP) to confirm that all clinical trial activities conducted ethically, scientifically, and in accordance with regulatory guidelines. Executed medical oversight for assigned projects, offering dual perspective encompassing both medical and scientific aspects.● Ensured continual observing for safety and well-being of study participants while accomplishing assigned monitoring duties, including safe guarding integrity of project data in adherence to clinical trial protocol/clinical study protocol.● Served as key liaison among liaison Sponsor/Client, holding responsibility for pivotal medical decisions within project, investigational sites, and project team, confirming seamless communication and collaboration.● Fostered and retained culture of transparency and adherence within clinical trial environment, guaranteeing compliance with all relevant directives and regulatory requirements.● Contributed to enhancing Business Development initiatives upon request by leveraging medical expertise to support and advance tactical growth opportunities.

Argentina

Collaborated with CROs overseeing clinical trials, determining optimal patient recruitment sites, assessing feasibility for each case, and participating in investigator meetings to monitor study progress. Supervised high-performing pharmacovigilance team and managed all reporting obligations to local regulatory authorities and external partners.● Ensured all processes, such as healthcare professional activities and management of medical institutions, scientific societies, and NGOs complied with set company standards and regulations while supporting product registration and marketing efforts.● Empowered business department with updated information to create strong and lasting growth approaches by scheduling and managing thorough training programs for sharing deep insights about products and competitors.

Argentina

Collaborated with CROs overseeing clinical trials, determining optimal patient recruitment sites, assessing feasibility for each case, and participating in investigator meetings to monitor study progress. Supervised high-performing pharmacovigilance team and managed all reporting obligations to local regulatory authorities and external partners.● Ensured all processes, such as healthcare professional activities and management of medical institutions, scientific societies, and NGOs complied with set company standards and regulations while supporting product registration and marketing efforts.● Empowered business department with updated information to create strong and lasting growth approaches by scheduling and managing thorough training programs for sharing deep insights about products and competitors.

Argentina

Engaged in overseeing medical areas encompassing nephrology, HIV, and neonatology, taking charge of planned initiatives and medical oversight. Provided indispensable scientific support to regulatory and commercial teams, ensuring product promotion and interactions with healthcare professionals, institutions, medical societies, NGOs, and social security adhere rigorously to company compliancestandards.● Participated in conducting necessary assessments, site selection, initial contact management with investigators, and dynamic contribution to Investigator Meetings in coordination with Research and Development Department.● Planned and executed local and regional advisory boards, round tables, and training workshops aimed at physicians, medicalauditors, and payers.● Led all facets of development and management of oncology therapeutic team, ensuring optimal performance and outcomes.

Buenos Aires

Focused on delivering high standard customer services by designing and executing marketing and commercial strategies, policies, and customer communication guidelines. Confirmed cohesive and effective operations management in collaboration with various company divisions, including medical affairs, regulatory, forecasting, and quality assurance.● Directed development and execution of strategic initiatives within critical medical domains while overseeing two pivotal therapeutic areas, such as pediatric and adult oncohematology, as well as pediatric and adult solid organ transplantation.● Created and utilized marketing plans, planned blueprints, and budgetary frameworks, driving company's forward-looking vision and financial policies.

Argentina

Launching of “Sprycel”, product for the treatment of chronic the Mieloide leukemia in November of 2006, surpassing widely (>200%) our budget 2007. Ours sales of Sprycel maintained a rate of permanent growth surpassing the objectives in 2008 and in 2009, strengthening to us like the first option of treatment in the indication of the product, with a market share of 78%.Launching of “Ixempra”, product for the treatment Metastatic Breast cancer managing to surpass our objective of sale in the region in spite of competing in a market saturated of products in its majority generic, overcoming the barriers for access to the treatments,specially in Chile and Peru, in where more than 90% of the market it is covered by the government.I received several prizes due to the outstanding results.Prizes: President Award in 2007 (sale Sprycel Argentina)ACCA Elite 2007 (Sales Unit of businesses) Andes Award 2008 (Sales regional Unit of Businesses)I achieved a sales force growth from 6 sales representatives in 2006 to 11 in 2009 (only in Argentina).Development of people: I led the process, obtaining the promotion of two people of my equipment in a year. (2009).One from other departement was included as first line manager inoncology. Also two other people, one fromfinance and one from Research made a rotation in the business unit as a career plan.

Argentina

Actively participation in the development of the strategic plan and marketing for launching of a new antiangiogénic, obtaining parallelly, and due to this management, the approval on the part of the USA stops that several centers of Argentina participates in clinical studies phase II-III and the opportunity to lead a compassionate trial with the drug with great repercussion in the medical community. I coordinated the beginning of the Multidisciplinary Course for Specialists in Oncology, by the M. D. Anderson Cancer Center, Houston, Texas, transmitted simultaneously by videoconferencia to 9 countries in Latin America. I reorganized the registry of oncológy practice with 6000 patients denounced (more of 14,000 cycles of treatment), according to the SOP´s de Pfizer, and I obtained the approval of the project from the corporation. I took ahead the analysis of the data. I designed and I coordinated the edition of the guides of oncológicy practice, with information updated on estadification, procedures diagnoses and strategies of treatment of all the tumors, the first one in Argentina, of enormous utility for the community of oncólogists. I maintained strenghs relationship with the KOL of different medical specialties: oncólogISTS, gynecologists, breast cancer specialists, urólogists, neurologists among others, as well as with the different medical associations. Work on the magazine that Pfizer published for all the community medicine professional and I wrote some articles.

Médica

Marketing Farmcéutico- Otros

Marketing Farmacéutico (Asociación Argentina de Marketing Farmacéutico), Advanced Product Manager Management Development “Brand & Launch.

Especialista En Oncología Clinica Y Quimioterapia