SUMMARY

People leader with ** years of experience in multinational pharmaceutical industry in Medical Affairs, clinical and research field.

Self-starter known to initiate process and system improvements to increase efficiency and productivity

Solid manager with a track record of hiring, supervising, and training successful teams.

Very good analytical skills and sense of urgent

Committed, passionate and responsible employee focused on business strategy

Excellent multidisciplinary working skills.

EDUCATION

PHD MOLECULAR BIOLOGY Universidad de Buenos Aires. SCORE:Outstanding. MASTER DEGREE: MEDICAL MOLECULAR BIOLOGY Facultad de Ciencias Exactas y Naturales. Universidad de Buenos Aires.

MASTER DEGREE: MEDICAL PHYSICS Facultad de Ciencias Exactas y Naturales. Universidad de Buenos Aires. BACHELOR’S IN BIOLOGY AND SCIENCES Facultad de Ciencias Exactas y Naturales. Universidad de Buenos Aires COLEGIO NACIONAL DE BUENOS AIRES Universidad de Buenos Aires OTHER TRAINING AND CERTIFICATIONS

Centeno Schultz Clinic: Management and isolation of stem cells for clinical use. Regenexx Technique Va Medical Center Study of osteoblast differentiation culture. Instituto de Investigaciones en Reproducción-Fecunditas In vitro fertilization techniques. Laboratorio de Fisiopatogenia–University of Buenos Aires. UBA PhD Fellowship Proyecto PICT-9508. Laboratorio de Biología Celular – University of Buenos Aires. UBA PhD Fellowship. EXPERIENCE

PTC THERAPEUTICS 2022 TO PRESENT

DIRECT REPORTS: 1

Associate Director-Medical Operations Lead SAM Region Jan 2022-Present

• Led teams of up to 7 personnel, supervising daily performance as well as training and improvement plans.

• Developed a diagnosis program in 12 countries performing a local analysis and giving consideration to special features and needs.

• Implemented business intelligence diagnosis dashboard tool in 12 countries benefiting a unique data management for the region which impacted on business strategy decisions.

• Executed over 50 contracts with external vendors developing a diagnosis program for 4 therapeutic areas offering the physician a diagnostic alternative.

• Implemented and managed 8 risk management plans for SAM region according Pharmacovigilance and FDA/EMA regulations.

• Grew strategic relationships with executive decision-makers fostering an environment of cross- collaboration between departments and achieving higher than usual outcomes.

• Maintained positive customer relations by addressing problems head-on and implementing successful CAPA actions.

• Challenged diagnosis and patient support program existing vendors structures, shifting to models benefiting PTC business strategy

• Leveraged data and analytics to make informed decisions and drive business improvements. LORENA

LEVI

1615 Moores mill rd. Atlanta. GA. 30327

754-***-****

ad2nra@r.postjobfree.com@gmail.com

://www.linkedin.com/in/lorena-levi-molecular-biology-phd-a044309 2

• 100% successfully managed budgets and allocated resources to maximize productivity and profitability.

• Cultivated positive rapport with fellow employees to boost company morale and promote employee retention.

Clinical Science and Diagnostic Lead South Cone Nov 2018- Dec 2021

• Implemented an innovative Diagnosis program and Risk Management plan for 4 therapeutic areas driving compliance and optimizing the pipeline management for South Cone region

• Worked in collaboration with other PTC areas to leverage multi-company contracts benefitting diagnosis and patient care.

• Implemented a Risk Management Plan in South Cone according to FDA and EMA regulations.

• Designed and led a family tree app project which led to the benefit of other PTC regions than SAM and it was translated in 2 languages.

ASPETAR CLINIC-QATAR SCIENTIFIC ADVISOR 2018- 2020

• Executed validation of over 20 regenerative medicine with stem cells cultures protocols across countries to develop a state-of-the-art technology positioning ASPETAR clinic as the most advance technology in the region.

• Leveraged data and analytics to make informed decisions and drive business improvements.

• 100% successfully managed budgets and allocated resources to maximize productivity and profitability. REGENERAR SA SCIENTIFIC DIRECTOR Nov 2013-Nov 2023

• Hired and trained team members currently in charge of leading daily activities and training sessions.

• Developed and validated of more than 30 scientific protocols based on stem cell cultures for human use successfully implemented in Colombia, Spain and Qatar.

• Led up to 10 personnel team in order to successfully achieve businesses goals.

• Proactively developed sourcing strategies around future technology innovations prioritizing interoperability in Regenerar ecosystem, multi-origin sourcing, and required protections

• Established workflow crossfunctional processes with marketing and commercial team to set a common strategy.

• Exercised leadership trust and respect policies by successfully motivating and inspiring team members

• Create, format, revise and proofread controlled documents Standard Operating Procedures (SOPs) and a Quality System.

• Building relationships with key opinion leaders and applies their input to enhance study design and protocols according GCP guidelines

• Ensured clinical research program design met scientific objectives and aligned with commercial needs

SANOFI GENZYME Clinical Science Associate (Medical Science Liaison MSL job equivalent) Aug 2013-Oct 2018

DIRECT REPORTS: 1

• Developed over 50 diffusion projects in rare disease

• Executed over 10 advisory boards in rare diseases

• Developed strategic relationships with Key Opinion Leaders fostering an environment collaboration MATERCELL SA Director of Laboratory Sept 2010-Dec 2013

• Hired and trained over 10 team members currently in charge of managing lab and logistic activities

• Developed and validated of more than 30 scientific protocols based on umbilical cord stem cell isolation and cryopreservation for human use.

• Created innovative quality system with over 200 standard operating procedures (SOP) according ISO 9001 guidelines and local regulations.

• Successfully executed ISO 9001 audits.

3

THOMSON FOUNDATION Study coordinator July 2006-December 2016 DIRECT REPORT: 2

• Principal Investigator: Dr Alberto Dubrovsky

• Followed at least 25 informed consent processes and maintained records

• Participated in up to 30 initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.

• Successfully led Independent Ethics Committee audits.

• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.

• Up to 5 protocols simultaneously running with 100% accuracy.

• 100% successfully conducted clinical trial in accordance with protocol and recorded and monitored progress following FDA regulations and GCP guidelines STEMATIX ARGENTINA Laboratory Director July 2009-June 2013 DIRECT REPORT: 3

• Performed over 50 scientific protocols based on stem cells for human treatment which improved at least 20 medical processes for more than 10 different diseases

• Transferred technology to at least 4 laboratories all over Argentina with 100% success.

• Developed and execute quality system with over 300 standard operating procedures according ISO 9001 guidelines and local regulations.

• Hired and trained over 10 team members

• Led strategic negotiations with external vendor savings exceeding $6M BLANCHARD Y ASOCIADOS Clinical Research Associate (CRA) 2008- 2011

• Monitored safety of human subjects and oversaw over 40 consent procedures to comply with local and federal regulations and Good Clinical Practices (GCP) guidelines.

• Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.

• Maintained site monitoring schedules to facilitate effective communication with members of clinical team

• Created and maintained over 200 records filing system to document data on specimen collection, processing and storage

• 100% successfully conducted clinical trial in accordance with protocol and recorded and monitored progress following FDA regulations and GCP guidelines. ACLIRES INTERNATIONAL Project Manager 2007- 2008

• Handling study documents in a timeliness manner

• Budget tracking for clinical trials

• Support the link with outsourced services

• To prepare and maintain all necessary documents (TMF, ISF, MOH,Ethics Committee)

• To assure the quality according to ICH/GCP guidelines

• Management of clinical trial budget

• To contribute to maintaining an excellent client focus and service-oriented mentality. UNIVERSITY OF BUENOS AIRES-FACULTAD DE FARMACIA Y BIOQUIMICA-CONICET PhD Fellowship 2006- 2008

• Implemented over 100 lab procedures to prevent errors and protect staff.

• Developed and implemented 20 new research and development protocols with 100% accuracy to improve accuracy of laboratory results.

• Inspected laboratory equipment to maintain good working condition for optimal results.

• Designed and executed more than 400 preclinical research protocols which led to 20 scientific publications

(10 local and 12 international) and 4 congress international meeting awards. 4

Laboratory assistant 2006- 2008

• In charge of more than 100 students and taught both practical a theoretical cell biology classes.

• Taught over 200 specialized biology classes for students in major and those completing graduate-level work.

• Demonstrated creativity and resourcefulness through the development of more than 50 innovative teaching classes which helped students better understand through lectures, discussions and assignments. COLEGIO MARTIN BUBER high school teacher 2004- 2007

• Taught over 90 high school students both theoretical cell biology classes.

• Demonstrated creativity and resourcefulness through the development of more than 60 innovative teaching classes.

• Designed detailed learning plans for struggling students based on test, homework and assignment records.

•

FESTEJAR SRL sales manager 1995-2004

• Developed strategic relationships with external vendors fostering an environment of cross-collaboration between departments and achieving higher than usual outcomes.

• Hired and trained over 50 team members.

• 100% successfully managed budgets and allocated resources to maximize productivity and profitability Acomplishments:

• AWARDS (4): IFPA (International Federation of Placenta Associations Placenta) 2006- 2007 (2)-2008. Intermédica: 2015

• SIMPOSIO MUNDIAL DE TERAPIAS CELULARES Y MEDICINA REGENERATIVA: President: 2017- 2018- 2019-2020.

• FUNDACIÓN BERNARDO HOUSSAY: Jury: Award 2012 given to Dr Diego Golombek.

• MAIMONIDES UNIVERSITY: Degree thesis jury 2012. “Stem cells and differentiation systems”. Ezequiel A. Migliore. score: Distinguished.

• LECTURES: UNIVERSIDAD CATÓLICA ARGENTINA: Speaker. 201*-****-****. THERAPEUTIC AREAS OF EXPERTISE Phase I, II, III, IV

• CNS

• HIV/AIDS

• EM (Diabetes)

• INFECTIOUS DISEASES (Hepatitis C)

• ONCOLOGY(Melanoma)

• DERMATOLOGY (Acne Vulgaris)

• DUCHENNE MUSCULAR DYSTROPHY

• FAMILIAL AMILOIDOSIS HEREDITARY

• FAMILIAL CHILOMICRONEMIA SYNDROME

• AADC DEFICIENCY

• POMPE DISEASE

• GAUCHER DISEASE

• FABRY DISEASE

• MPS DISEASE

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