Genice possesses over 20 years of experience in clinical affairs. She joined Experien Group (now Veranex) in 2019 to expand the firm’s clinical department with her experience in managing all aspects of clinical studies from study strategy and design through data analysis and clinical report generation.
At Veranex, Genice oversees the clinical team by supporting clients with both setting strategic direction and evidence pipeline as well as detailed tactical planning and execution for converting a company’s goals into actionable preclinical and clinical studies for medical devices and combination products. Her central responsibilities include:
- Participating on design teams throughout the product life cycle
- Providing clinical strategy development expertise to assess the optimum clinical strategy for the client’s study goals
- Directing clinical elements and generates clinical study documentation required for FDA submissions to support clinical research, including pre-submission packages and investigational device exemption (IDE) applications, as well as final clinical study reports for de novos, 510(k)s, PMAs, and EU technical files
- Leading clinical study operations from enrollment planning to close-out in accordance to projected timelines, including study/site activation activities, management of clinical study databases, formulation and facilitation of Data Safety Monitoring Boards (DSMBs), Clinical Events Committees (CECs), and core labs with the study sponsor to ensure study success
- Providing clinical functional expertise and support for business development opportunities, including managing the clinical-related requirements, deliverables, and oversight associated with pre-acquisition and investment due diligence efforts
Past companies and experience
Prior to Veranex, Genice spent fifteen years with Medtronic in roles of increasing leadership capacity in the clinical affairs discipline of various divisions. She garnered product experience with significant risk technologies, non-significant risk (NSR) technologies, active implants, capital equipment, implantables, software as a medical device, medical instrumentation, and combination products, including shunts for hydrocephalus (cerebral spinal fluid shunts), cranial repair products, navigation/imaging and robotics for spinal and cranial applications, pain “dressing” for tonsillectomies, sleep apnea products, nasal valve collapse products, and laser ablation for neurosurgical procedures. During this tenure, Genice gained broad and invaluable experience serving as a member of the Medtronic Global Clinical Council, a governance council comprised of executive clinical leadership from targeted businesses and geographies of Medtronic, was the executive sponsor of the EU MDR clinical workstream overseeing global enterprise-wide (across Medtronic) implementation of cost-effective, harmonized, strategic solutions to meet the new EU MDR requirements, and received the Medtronic Global Clinical Excellence Award twice for her leadership. Prior to that experience, Genice held clinical positions at McGhan Medical (now Allergan), Computer Motion (now Intuitive), and Quintiles CRO (now IQVIA).
Genice earned her B.A. in kinesiology with a minor in psychology from Westmont College in Santa Barbara.