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This position provided leadership for the Study Site Engagement (SSE) team, a global team of regionally based individuals who were the ‘regional face’ of the company for study site relations, supporting clinical program activities through efficient site-centric management to ensure study timelines and milestones are met.The SSE role was three-fold in (1) providing clinical study support to investigational sites and study teams, (2) contributing to sponsor oversight through liaising with CRO-CRAs on site and performing monitoring oversight visits, and (3) serving as clinical point of contact for cross functional communication with Global/Regional Medical Affairs and other regional R&D functions.

This position provides leadership for the Study Site Engagement (SSE) team, a global team of regionally based individuals who are the ‘regional face’ of the company for study site relations, supporting clinical program activities through efficient site-centric management to ensure study timelines and milestones are met.Initial focus in 2016 was on the role harmonization of legacy Baxalta and Shire site engagement teams (14 individuals located in 11 countries across the globe - US, Latin America, Europe and JAPAC). In Q3 2017 co-monitoring functions were added to build one site facing team (19 individuals total).The SSE role is three-fold in (1) providing clinical study support to investigational sites and study teams, (2) contributing to sponsor oversight through liaising with CRO-CRAs on site and performing monitoring oversight visits, and (3) serving as clinical point of contact for cross functional communication with Global/Regional Medical Affairs and other regional R&D functions.

Transitioning from Baxter to Baxalta, this position provided senior medical leadership for the South Europe cluster (France, Italy, Spain, Portugal, Greece) in the therapeutic area of Hematology, delivering the medical strategy for Medical Affairs Hematology at a cluster level in line with global and regional Medical Affairs business needs. This position included leadership and management for up to 20 individuals.

This position is best described as consultant to internal and external customers of Baxter’s Hemophilia Franchise in the EMEA region. Major elements were the provision of medical/clinical expertise on Baxter’s haemophilia products, participation in strategic assessment around product development, as well as life cycle management and support of marketed products. Specifically, this included the development of a software medical device to facilitate individualized PK-guided dosing in hemophilia A patients (myPKFiT®).

In 03/2004 Baxter BioScience’s Global Clinical R&D Department was reorganized and a Clinical Operations group and Therapeutic Areas were formed. Within the Therapeutic Area of Immunology and Vaccines, this position focused on the elaboration of clinical strategies (including protocol design for clinical studies) associated with Baxter BioScience’s vaccines products. Major elements were the provision of clinical development expertise for overall product development, as well as the support of regulatory and life cycle management / marketing activities. Achievements were the European mock-up licensure of the first cell culture derived H5N1 pandemic influenza vaccine in March 2009, as well as the licensure of the pandemic vaccine Celvapan® H1N1 in October 2009. This position included leadership for 2 to 4 individuals.

This position carried responsibility for clinical development and support of medical affairs activities associated with all of Baxter BioScience’s vaccines products and projects: FSME- IMMUN (TBE - tick borne encephalitis), NeisVac-C (Meningitis C conjugate), PrefluCel (cell culture derived Influenza), Lyme borreliosis and others. This included leadership and departmental management for the clinical development team in Vienna (up to 20 individuals, including CPMs, CRAs and project coordinators).

In this position the main responsibilities were the planning and realization of national and iternational clinical studies phases I to III, including the development of clinical trial protocols, regular contacts with investigators and opinion leaders, budgeting of clinical trials, central monitoring, compilation of progress reports and final clinical study reports.