Experience

Cormedix Inc.
• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Senior Medical Science Liaison

  • Jul 2023 - Present


Transplant Genomics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director of Clinical Trials/Director of Medical Affairs

  • Mar 2021 - Sep 2022

  Director of Clinical Trials: • Led the clinical trials program which included revamp of TRULO registry and development and launch of 10 US and global multi-center trials. • Increased total revenue for Transplant Genomics and monthly enrollment in biomarker registry from 30 to 100 patients in 6 months. • Maintained/built strong relationships with principal investigators and coordinators; established quarterly meetings with 50 registry sites to improve communication about barriers to success. • Built and maintained strong partnerships with investigators/external stakeholders, including CROs, data management systems, and professional organizations to ensure successful enrollment. • Handled budget and contract review to ensure rapid turnaround time during study startup. • Reviewed feasibility surveys and conducted 50 SIVs for 10 clinical trials; improved data collection and quality after selecting a new electronic data capture system. • Created and implemented clinical development plan and operational strategy. Provided clinical operations leadership for medical affairs. Director, Medical Affairs: • Developed medical affairs strategy for TruGraf kidney, TRAC, Omnigraf, and TruGraf Liver biomarkers including launch of OmniGraf and TruGraf Liver; created promotional decks and trained commercial team on unique product science/technology. Functioned as a national MSL for key accounts. • Managed and trained 10 MSLs; provided leadership related to KOL engagement/insight generation, directed and expanded advisory board program and speakers bureau; hired four new professionals. • Created and launched investigator-initiated research program; approved 12 IIRs during first year; • Wrote SOP for PRB; chaired meetings to ensure compliance and scientific accuracy of customer facing materials. • Developed and maintained relationships with over 100 organ transplant and nephrology KOLs in United States and Europe. Show less



Veloxis Pharmaceuticals, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Independent Consultant

  • Jan 2012 - Mar 2021

  • Served as a market access consultant to assist with obtaining commercial coverage for Envarsus (Tacrolimus ER), a calcineurin inhibitor. Participated in advisory boards, developed letters to insurers with other KOLs from COEs, and met with insurers to achieve this goal. • Participated in quarterly advisory boards to provide guidance on medical affairs strategy and protocol development. • Educated KOLs on the scientific data supporting Envarsus including its unique pharmacokinetic and pharmacogenomic profiles during and after launch. Show less



University of Illinois Chicago

• United States
• Staffing and Recruiting

• Chair, Institutional Review Board

  • Jun 2011 - Mar 2021

  • Chaired committee of 10 multi-disciplinary clinicians at University of Illinois-Chicago; trained members on regulatory requirements including ICH and GCP and ensured diverse membership reflecting protocol submissions. • Reviewed and approved protocol and ICFs for one of the largest research institutions in Chicago; including hematology, oncology, ophthalmology, and endocrinology;• Verify adequacy of informed consent document for informing participants about research, including risks and benefits. Evaluate inclusion/exclusion criteria for appropriateness and adequacy.• Ensured that reports related to safety, noncompliance, unanticipated problems in research and adverse events are reported pursuant to federal regulations.• Worked closely with principal investigators in the Cancer Center to train coordinators and ensure compliance with hematology and oncology protocols. Conducted audits of high-risk studies quarterly. Show less

• Director of Transplant Research

  • Jun 2006 - Mar 2021

  • Directed and managed clinical research unit at the University of Illinois in the Department of Surgery.• Served as principal investigator for 50 clinical trials; preferred PI/site by clinical research organizations, to participate in studies because of reputation for data quality, timeliness, and number of enrollees; known for enrolling more patients than other sites.• Overcame barriers to successful enrollment of patients in eculizumab study for kidney transplant patients at high immunologic risk by personally handling consent process and medication delivery in operating room to ensure compliance with protocol. • Trained coordinators on data entry requirements for immunologic and pathology data; ensured accurate/complete data entry for clinical trial endpoints that reflected source documentation; recognized by CROs for high quality data (ALCOA-C). • Recognized for expertise on pharmacokinetics and pharmacogenomics of immunologic medications and medication adherence; 30 publications in high impact journals and 50 presentations at national conferences. • Managed a team of 10 study coordinators, regulatory coordinators, and research nurses. Mentored surgical research fellows on their research projects which included medical devices and surgical oncology. • Ensured adherence to standard operating procedures, good clinical practice and FDA regulations and created standards and guidelines for clinical research services and programs.• Conducted internal audits to ensure compliance with GCP. Show less