Dr. Vigdorth has 30 years of drug development research experience in the clinical setting and pharmaceutical and CRO industries. She has led clinical development programs across a range of therapeutic indications with extensive experience in antibiotic, antiviral, vaccine, and antifungal agents. Her therapeutic experience includes: anti-infectives, allergy, ob/gyn, pain control and management, immunology, respiratory, and ICU/ER (MICU, NICU, Burn) She has extensive international experience operationally, developed an internationally represented PM team, and worked successfully with sponsors globally in large pharma to virtual biotechs.
Operationally, she has served as Program Director for multiple compounds. Her responsibilities have spanned both scientific and cross functional operations in global projects. Her depth of experience includes drug development from the filing of the IND, drug development plan, protocol design, study conduct, and final clinical study reports to regulatory authority submissions, responses to the FDA/EMEA/NDS and advisory panel preparations.
As a Program Leader, Dr Vigdorth has held responsibility for the oversight and integration of information across functional departments such as Clinical, Medical, Regulatory Affairs, Data Management, Biostatistics and Quality Assurance. She has coordinated programs which included multiple CROs and vendors. She has served as senior company representative for Sponsors and as their liaison with Quintiles operations. She has been responsible for the development of a partnering relationship with a number of Sponsors which has resulted in non-competitive and repeat business awards. Throughout her career, Dr Vigdorth has had increasing responsibilities operationally and functionally, as demonstrated by line management experience over Executive and Senior Project Management Associates, Clinical Operations, IT systems and applications, Safety Data Reporting, and Data Management.