Dragana Males
Director, Medical Safety Physician @AbbVie
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WORK HISTORY
Director, Medical Safety Physician @AbbVie
Irvine, CA, US
ABOUT DRAGANA MALES
My strengths:• European and USA work experience• International Clinical Trials experience• 25+ years of clinical research experience in Pharmaceutical companies and CROs (phases I-IV)• IND Submissions• European Board-Certified Pulmonologist (9 years as practicing physician) Therapeutic areas strengths: • Respiratory • Infectious Diseases• Women’s Health• Dermatology• Gastroenterology• Psychiatry• Medical DevicesExperience:Medical Monitoring • Global medical/scientific advisor duties• Program design• Study Design • Development of protocols, investigator brochures and the product safety profile.• Providing clinical trial training to the study team, sites, vendors etc.• Providing disease-specific medical training for the team & sales team• Helping the team and the sites with strategies to enhance the subjects’ recruitment.Clinical drug/device development • General strategy• Clinical program strategy • Work with manufacturer on product development• Participate in FDA or other health authority interactions• IND/NDA medical/clinical sectionsPharmacovigilance Clinical Operations • Developing strategies• Leading large teams
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