Engineer Clinical Research

Jason M. Lewen

Miami, FL ***** 646-***-**** ***********@*****.*** www.linkedin.com/in/Jason-Lewen

CONSULTANT / PRINCIPLE CLINICAL ACCOUNT LEADER (Clinical Affairs) - MEDICAL DEVICES

Proven executive leader and clinical affairs strategic account manager with extensive experience in clinical research of medical devices in the cardiac, and vascular specialties. Consult with key stakeholders of global organizations and start-up leadership to devise and implement critical strategies and best practices to launch and maintain clinical trials and process improvements initiatives. Collaborate with and lead cross-functional teams, acting as subject matter expert.

CORE COMPETENCIES

Consulting Medical Devices Clinical Trial Development and Execution Program Management Project Management Collaboration Large Medical Device Companies Start-Ups Cross-Functional Team Leadership Six Sigma Mentoring

EXPERIENCE

Consultant, Medical Device Clinical Trials 11/2019 - 2/2020

Provide consulting to growing start-up organization with clinical trial planning.

MEDTRONIC, INC., Minneapolis, MN 07/2005 – 04/2019

Principle Clinical Account Leader, Cardiac and Vascular Group, (Clinical Affairs) 04/2013 – 04/2019

Led Core Team focused on clinical trial execution.

Lean Sigma Black Belt and Lean Sigma Coach and Mentor.

Lean Sigma Tiger Team Project Ecosystem (expanding Lean Sigma within CAL Org, creating financial project model, project section process, instructed Lean Sigma education exercises, collaboration with ProCV team / model).

Initiated & led project teams to create tools for overall clinical organization to drive clinical trial efficiency and execution (Enrollment Strategy Tool, Activation Metrics tool, Subject Transfer tool, “Finishing Well” tool, Historic Enrollment CDA tool.

Led Enrollment Strategy Decision Tool Project (Proof of Concept Project).

Founded and Led CRI Research Summit Program development planning team (17 cross-functional and cross-business unit members and multiple subcommittees, directing over 150 contributors and touchpoints) for three consecutive years (original creation and year over year improvement and program expansion) to form implementation strategies to key clinical trial landscape issues and share best practices amongst top national research institutions. (Each year 85-89% strongly agree, and remaining 11-15% agree they would recommend the program to their peers.)

Presented findings to stakeholders key best practice learnings from Summit with MDT through clinical grand rounds, SBU Liaisons meeting, and specific BU tailored presentations, resulting in improved several work flow efficiencies.

Through Influence Management, I directed a clinical trial portfolio at key accounts for clinical trials execution

Cross-functional collaboration with Medtronic study teams, Regulatory, Legal, Contracts, Monitoring, Statisticians, Data Scientists, and other clinical leaders across multiple business units to ensure issues are quickly resolved and opportunities are fully realized.

As Facilitator of Clinical Account Leader Council, I led a team focused on creating change and completing projects to enhance the CAL organization including; CAL council charter, CAL elevator speech, FY15 metrics for evaluation, MBO alternative compensation project, Employee engagement feedback project, Core team transition Q&A, CRI center classification project, CAL national meeting planning)

Site Nomination Process Regional Leader - directed and led field site nomination process.

Study Liaison Team (SLT) for Intervene-HF, Marvel, and Marvel 2: helped edit and develop protocol, influenced protocol version changes, study worksheets, enrollment materials, follow-up compliance plans, and other tools, offered site perspective, optimizing patient flow for enrollment and follow-up.

Extremely engaged member of several cross functional and business unit teams (Diversity in Enrollment Initiative with African Decent Network, Electronic Consent Team, SLT teams).

Experienced presenter to Hospital COO’s, Administrators, Medtronic Senior Leaders, Medtronic Clinical.

Study Process Center of Excellence.

Dedicated field-based clinical resource for CVG study and Center for Research (CRI) strategy execution.

Managed clinical trial portfolio for Medtronic at key strategic hospitals, implementing strategies to drive consistent study performance improvements, and consistently hitting and exceeding study objectives. (107% of objectives met in 2019, 106% in 2018, 104% in 2017, 102% 2016)

Technically supported 1st MICRA implant cases for launch in Israel.

Trained European Physicians on MICRA implant procedures at Physiological Research Laboratories.

Principle Cardiovascular Research Consultant/

Field Clinical Engineer, Cardiac Rhythm and Disease Management, 11/2010 – 04/2013

Leveraged and built collaborative relationships with site personnel (KOL’s, physicians, research coordinators, and administrators) across the CVG Businesses in NY and NJ Centers for Research Innovation.

Effectively navigated site-specific research processes to successfully execute clinical research and deliver on the CVG Portfolio milestones.

Provided general knowledge of CVG technologies and products.

Facilitated stakeholder and executive visits.

Conducted quarterly CVG clinical reviews (site performance metrics, dashboards and actions).

Facilitated scientific discussions around clinical studies, portfolio strategy and evidence dissemination.

Used creative problem-solving to resolve site management and study issues.

Served as co-facilitator of FCE Council.

Senior Field Clinical Engineer, Cardiac Rhythm and Disease Management, 07/2005 – 11/2010

Supported numerous pre-market and post-market clinical trials for pacemaker and defibrillator implants through various stages - from activation to enrollments to implants to follow-ups - in NY and NJ area hospitals.

In FY2010 was ranked second highest enroller out of a 55+ field clinical team while maintaining a 97.8% subject follow-up compliance rate.

Acted as liaison between internal clinical department, Medtronic sales, and hospital personnel/physicians (Electrophysiologists, Cardiologists, Interventionalists, Heart Failure Physicians, Radiologists, RN’s, NP’s, PA’s, Clinical Coordinators, Contract departments, Investigational Review Boards).

Probed physicians and centers to nominate centers with the greatest chance of clinical trial success.

Met with physicians to engage research interests and physician initiated research ideas.

Trained hospital personnel and Medtronic sales partners in new devices and clinical protocols.

Mentored and trained new field clinical engineers as a senior FCE in the northeast region.

Cross covered multiple Northeast territories during times of transition.

Led technical device classes to Medtronic in-house clinical department.

Hand selected to serve on several different committees (Clinical budget tool creation team, PASS Compensation Project, Field Clinical Advisory Team, Episode teams, Vests/Predicts site activation team).

AXIOM MEDICAL, St. Rancho Dominguez, CA 07/2004 – 10/2004

Biomedical Engineer Graduate Intern, Research and Development

Wrote SOP’s for R&D projects.

Tested flow properties and mechanical properties of multiple products.

Designed tests to be repeatable and adaptable.

MODERN MEDICAL SYSTEMS/APPLIED BIOMEDICAL

@ THE HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA, Philadelphia, PA 01/2002- 12/2003

Biomedical Clinical Engineer

Performed OR, ER, EP LAB, SICU experience and on-call duties.

Worked in a health system network traveling to several hospitals to service equipment.

Conducted in-services on equipment, teaching nurses and hospital staff on hospital equipment.

Organized and conducted ventilator testing to determine cell phone/wireless interference.

Created system for maintaining preventive maintenance schedules on 20,000 medical devices.

Redesigned automated pneumatic acupuncture device.

Performed preventive maintenance and repairs of all biomedical devices including physiological monitors, infant incubators, centrifuges, telemetry systems, and EKG machines.

Specialized in ventilators and all respiratory equipment.

Interacted with hospital administration, department managers, head nurses, doctors, and engineers.

EDUCATION

Master of Science (MS), Biomedical Engineering, Medical Device and Diagnostics

Verterbi School of Engineering, University of Southern California, Los Angeles, CA

Bachelor Science (BS), Mechanical Engineering

Watson School of Engineering, Binghamton University, State University of New York, New York, NY

SKILLS / AWARDS

Successful Program and Project Management Skills and Projects

Lean Sigma Black Belt

Contributions made to the MICRA IDE clinical Team Global Clinical Research Excellence Award

Field Clinical Organization Region Contributor of the Year FY2013

CEO Inclusion Award

CRDM Star of Excellence 2007

eCornell Leadership classes (Managing Strategic Change, Introduction to Project Management, Mining Collective Intelligence, Influence Without Authority)

Medtronic trainings (Effective Team Communication, Business Interpersonal Communication Skills, Delegation, Influence Management,

Reality Based Leadership Seminar

Technically proficient on pacemakers, defibrillators, cardiac resynchronization therapy, implantable loop recorders

Technically trained on coronary stents, abdominal and thoracic endovascular grafts, surgical heart valves, transcatheter heart valves, renal denervation, cardiac arrhythmia ablation, peripheral vascular products

Co-author published AHA abstract, “Resynchronization is Associated with Reduced Ventricular Arrhythmias” and Journal of Cardiovascular Electrophysiology manuscript “Relationship of Reverse Anatomical Remodeling and Ventricular Arrhythmias after Cardiac Resynchronization”

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