Experience

Haystack Oncology
• United States
• Biotechnology Research
• 1 - 100 Employee
• Sr. Director Regulatory Affairs

  • Aug 2023 - Present


Resolution Bioscience

• United States
• Biotechnology
• 1 - 100 Employee

• Sr. Director, Regulatory Affairs

  • Apr 2021 - Apr 2023

  Kirkland, Washington, United States Responsible for the development and implementation of Regulatory Strategies for registration of Resolution Bioscience's Products. In this role, I was responsible for the overall Regulatory compliance and oversight at Resolution.

• Director, Regulatory Affairs

  • Jul 2019 - Apr 2021

  Seattle, Washington



NanoString Technologies, Inc.

• United States
• Biotechnology Research
• 500 - 600 Employee

• Director of Regulatory Affairs

  • Sep 2018 - Jul 2019

  Greater Seattle Area Responsible for the development and implementation of Regulatory Strategies for registration and commercialization of NanoString products (including Reagents, Software, and Instruments) worldwide. Regulatory Lead for large scale projects which included Companion Diagnostics.

• Sr. Manager Regulatory Affairs

  • Jan 2018 - Aug 2018

  Greater Seattle Area



Ventana Medical Systems

• United States
• Biotechnology Research
• 700 & Above Employee

• Regulatory Affairs Manager

  • Mar 2014 - Jan 2018

  Tucson, AZ Provided Regulatory input to cross functional project teams in support of the development of Companion Diagnostics in collaboration with pharmaceutical partners; Led submission activities and interaction with Regulatory agencies for a variety of device regulatory approvals including CE mark, US premarket approvals (PMAs), PMA supplements, US premarket notifications, 510(k)s.

• Clinical Research Associate

  • Oct 2012 - Mar 2014

  Tucson, AZ Certified Clinical Reseearch Associate (ACRP) Responsible for qualification and monitoring of Clinical Trial Sites. Served as a point of contact for Pharmaceutical partners and Laboratories in support of proper Clinical Trial conduct

• Project Manager

  • Dec 2008 - Oct 2012

  Translational Diagnostics Maintained collaborations with Pharmaceutical Companies in development of contracts, budgets, and work plans for potential companion diagnostic projects; Provided oversight of clinical research studies from setup to closeout. Served as a point of contact for budgeting and invoicing, sample management, data monitoring and management, and information dissemination to team members;



Arizona Cancer Center, University of Arizona

• United States
• Medical Practices
• 1 - 100 Employee

• Research Specialist, Sr. (Sr. Clinical Research Coordinator)

  • Jul 2005 - Dec 2008

  Tucson, AZ Assisted in obtaining informed consent forms from potential patients; Coordinated and implemented procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; coded, evaluated and interpreted collected data and prepared appropriate documentation; Screened patients for clinical trial eligibility; Reported Serious Adverse Events to Pharma/IRB; Prepared continuing review reports for IRB and Data Safety Monitoring Board… Show more Assisted in obtaining informed consent forms from potential patients; Coordinated and implemented procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; coded, evaluated and interpreted collected data and prepared appropriate documentation; Screened patients for clinical trial eligibility; Reported Serious Adverse Events to Pharma/IRB; Prepared continuing review reports for IRB and Data Safety Monitoring Board (DSMB); Collected and submitted data forms and pathology materials according to protocol requirements; Prepared progress reports for investigators; Developed case report forms for investigator initiated clinical trials; Participated in the development and writing of standard operating procedures for the data management group; Maintained communication with team regarding regulatory and safety issues as well as any concerns that reflect upon Good Clinical Practice. Show less