Will Collis-Prather Email & Phone Number

Minneapolis, Mn, Us

-Adjunct faculty in the Applied Clinical Research Masters Program-Preparing and leading graduate level courses for students pursuing an advanced degree in clinical researcho Clinical Risk Management and Safetyo Clinical Study Operations and Execution

Currently a member of the RTG Pain Therapies leadership team as the leader of RTG Implantable Therapies Global Clinical Programs – leading a team of 100+ clinical research professionals (US, Europe, Australia, China) executing on clinical trials across 5 Medtronic RTG businesses.Currently responsible for leading teams in pre- and post-market clinical study execution, statistics, clinical quality, operations, ERP management, clinical training, medical writing and field clinical scientists/engineersPlan and oversee a clinical budget of up to $20 million annuallySuccessfully executed a culture change with respect to employee engagement and inclusion, improving overall metric by ~40 points based on a standardized Organizational Health Survey.Previously acted as clinical leader on Pain Therapies business leadership team; responsible for global clinical strategy and clinical insight into business and product development decisionsPreviously lead an international clinical group running clinical programs focused on treatments for atrial fibrillation (US, Europe, Japan) that included IDE studies (new products and indications), FDA Post-approval studies, postmarket studies and ERP studiesDeveloped a clinical strategy process for identifying and filling clinical evidence gaps

Lead an international clinical group of multiple cardiovascular clinical programs (US, Europe, Japan) that included IDE studies (new products and indications), FDA Post-approval studies, postmarket studies and ERP studies (therapies include AF ablation tools, implantable prosthetic heart valves and endovascular stent grafts)Built a 30+ member clinical team from the ground up for a newly acquired transcatheter heart valve business Lead a Europe-based clinical group to design and execute large global clinical trialsProvided strategic and functional direction to international clinical teams (Australia, Japan, EU, India, Canada, China) on regulatory and postmarket clinical programsManaged “Key Opinion Leaders” as stewards of the clinical business by providing business strategy and regulatory guidanceLead a physician-sponsor IDE program made up of eight PSIDEsManaged, mentored, and provided work direction to portfolio managers, study managers and functional managersPlanned and oversaw a clinical budget of up to $75 million annuallyDirectly negotiated with FDA on multiple clinical strategies for IDE and Post-approval trials, as well as PMDA (Japan) and SFDA (China)Participated on multiple cross-functional core teams as the clinical representativeDeveloped a talent acquisition and employee retention strategy, based largely on manager expectation setting that ultimately reduced turnover from 50% to 5% over two yearsEstablished Clinical Review Board to drive study execution and shared accountability across a multi-therapy clinical organizationWorked with CRO to close out legacy trials and successfully respond to FDA PHN threatSit on the MSSO MedDRA Expert PanelSit on multiple AdvaMed Working Groups (Atrial Fibrillation and Heart Valves)

Lead a premarket cardiovascular clinical group (~35 people strong) that included five clinical trials and a centralized adverse event review group (therapy included implantable pacemakers and defibrillators)Managed, mentored, and gave work direction to clinical trial leaders; including IDE studies for new CRT-D features and indication expansion, conditional of approval studies for IPG, CRT and CRT-D devices, and market release studies for new device platformsChaired two leadership teams, one to improve retention, develop efficient management processes and communicate best practices, and one to review promotions to ensure fairness and consistency within the departmentOversaw a clinical budget that averaged $5.5 million annuallyDeveloped and grew a centralized adverse event review group from zero to eight people that incorporated MedDRA into an automated, centralized adverse event review and reporting process; Regularly met with physician customers brought in by the sales organization as a representative of clinical organizationWorked as a Clinical Core Team Member in a cross-functional core team to drive the release of a new pacemaker platformNegotiated with FDA medical reviewer to achieve approval of PMA for new pacemaker/defibrillatorAuthored PMA-S submission to change device labeling based on European post-market study, which included partnering with European clinical colleagues. Authored two PMA-S clinical reports for FDA submission (left ventricular lead and CRT-ICD) and fielded questions and clarifications from FDA reviewersManaged resource allocation of US trial leaders to Europe to fill unmet clinical needPartnered with Talent Acquisition in recruitment presentations at local graduate schools

Managed all aspects of a 28-site significant risk device (heart valve) clinical trial.Authored clinical trial protocols and FDA annual reports.Conducted study start-up visits to train coordinators and support staff at investigational sites.Monitored sites for adherence to investigational plan and all applicable FDA CFRs and ICH GCP guidelines.Reviewed adverse effect source documentation and authored adverse effect narratives for clinical summary filings and Data Safety Monitoring Board review.Provided clinical decisions, directives and priorities to biostatistics, regulatory and marketing departments.Attended interdepartmental project meetings as the clinical representative for purposes timeline and budget forecasts.Trained and supervised junior level clinical research associate.Ensured all in-house and on-site study documents are appropriately maintained.Created monitoring tools for efficient tracking of protocol compliance by sites.

Authored clinical trial outlines, protocols, informed consent forms, monitoring plans, clinical investigator brochures and final reports for OTC drug and non-significant risk device studies.Directed development of case report forms and reviewed their validation guidelines.Identified and qualified investigators for clinical studies, including the preparation, collection and maintenance of necessary study documentation.Prepared required documents for the manufacturing, labeling and shipping of study-related materials.Hired and trained CROs for site initiation and monitoring activities.Negotiated site-specific study budgets and managed all investigator payments.Organized and executed investigator meetings and on-site initiation visits.Conducted on-study and close-out site visits to monitor for adherence to investigational plan and all applicable FDA CFRs and ICH GCP guidelines.Processed adverse event reports for timely review by medical monitor.Verified study databases and processed data clarifications for clinical study data.Designed and exhibited poster presentations for professional meetings.Conducted, analyzed and reported on eye care product characterization studies.

Managed academic research programs in the area of population ecology.Lead teams of scientific divers to conduct experiments in marine enviroments.

M.S., Biology

B.S., Biology

Activities and Societies: Student Government Phi Kappa Tau Fraternity