KRISTIN RUFFNER, PH.D.

4736 Harriet Avenue * Minneapolis, MN 55419 * (612) 867-1073 * krd870c2@westpost

.net
Strategic thinker and effective leader with expertise in clinical research.
PROFILE
History of recruiting and mobilizing high-performance clinical teams to execute
multi-site trials. Adept at multi-million dollar contract negotiation and budget
management. Extensive international business experience, including Europe, Asia
, Latin America, Canada, and Australia. Expertise in Lean Six Sigma, Value Stre
am Mapping, Total Quality Management and Virtual Reality Simulation. Outstanding
rapport building, presentation, and facilitation skills.
CORE COMPETENCIES
Negotiation Cost Reduction Clinical Audits
Quality Control Change Management Clinical Trial Design
Process Improvement Regulatory Compliance Product Development
Data Analysis & Reporting Organizational Development Marketing & Product Plannin
g
PROFESSIONAL EXPERIENCE
AMERICAN MEDICAL SYSTEMS, Minnetonka, MN
World's leading independent company focused on developing, manufacturing and mar
keting medical devices that restore male and female pelvic health.
Director, Clinical Operations and Field Clinical Research (2007 - 2010)
Planned and led major clinical research initiatives, including $5 million annual
budget. Supervised 30 field-based and internal clinical research professionals
that provide data management, programming, statistical analysis, reporting, moni
toring, auditing, compliance, training, and investigative site management suppor
t for all global clinical studies. Increased data management efficiency by manag
ing development of clinical information systems and the design and implementatio
n of tools and applications. Orchestrated new documentation architecture and imp
lementation of automated documentation system.
* Designed corporate clinical organization and expanded department from 7 employ
ees to 30 in 3 years.
* Drove progress of major initiatives, including: implementation of 20+ clinical
databases, publication of 50+ manuscripts and abstracts, establishment of 30+
new standard operating systems, and creation of 3 annual clinical strategic plan
s.
* Planned and oversaw annual Leadership Summit for top 80 leaders in company.
* Established audit function and coordinated 10+ internal and external audits.
* Led creation and execution of 4 clinical CAPAs (Corrective and Preventive Acti
ons) based on significant audit findings.
* Advanced 2 new technologies by contributing to due diligence process and creat
ing clinical strategies.
* Led 4 comprehensive change management programs and Oz Principal Accountability
training sessions for 60+ clinical professionals from 4 business units.
* Optimized clinical data flow process by overseeing Value Stream Mapping projec
t.
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Kristin Ruffner, Ph.D. / Page 2 of 3
CLIENTS: SPINEOLOGY, ATRITECH and UROLOGIX, Minneapolis, MN
Urologix, Inc. (leader in less invasive technology for benign prostatic hyperpla
sia), Atritech, Inc. (clinical stage medical device company, developing minimall
y-invasive technologies for prevention of atrial fibrillation-related stroke.),
and Spineology (developer of products to treat spinal ailments and reduce invasi
veness of spine surgery).
Clinical Director Consultant (2005 - 2007)
Managed all clinical research activities, including feasibility trials, pre-mark
et/IDE trials and post-market studies. Liaised with regulatory agencies, clinica
l investigators, and clinical trial staff domestically and internationally. Deve
loped, reviewed, and approved Clinical Investigational Plans, Institutional Revi
ew Board, and Ethics Committee submissions. Reviewed all data prior to submissio
n to FDA or other regulatory authorities. Authorized labeling and marketing lite
rature for appropriate claims during ongoing trials. Led adverse event reporting
, Clinical Event Committee adjudication activities and Data Safety Monitoring Bo
ards. Oversaw site selection and monitoring.
* Directed field monitoring team throughout clinical trials, domestically and in
ternationally.
* Created clinical strategies and protocols for all 3 companies.
* Developed training program and conducted training for internal and field-based
employees.
* Planned and coordinated 2 audits
* Increased corporate capabilities by recruiting and selecting internal clinical
staff, doubling clinical staff count.
* Negotiated 10+ physician contracts
MEDTRONIC, INC., Minneapolis, MN
$15.8 billion global leader in medical technology designed to alleviate pain, re
store health, and extend life for people with chronic conditions.
Director, Marketing and Training (2002 - 2005)
Created 10-year strategic plan, 5-year product portfolio, and balanced scorecard
. Implemented process for product definition and development. Established Produc
t Planning and Procedure Training Departments. Oversaw development of training c
ontent, tools and execution. Conducted 20+ physician advisory forums. Implemente
d product and cycle-time excellence concepts, techniques, and management practic
es for Cardiac Rhythm Management Therapy Delivery.
* Oversaw 6+ feasibility studies to define implant procedures for heart failure
and other cardiovascular medical devices.
* Originated Product Review Committee and chaired 10+ Product Review Committee f
orums.
* Negotiated multi-million dollar license agreement with strategic business part
ner.
* Launched state-of-the-art-training center with simulated operating suites in U
.S., Europe, Latin America, and Asia. System was used to train 6,000+ physicians
annually.
Senior Product Planning Manager (2000 - 2002)
Interacted with key opinion leaders and customer contacts to define customer req
uirements for all Cardiac Rhythm Management Therapy Delivery product segments. D
evised strategic business plans to support product funding. Developed and manage
d $1 million budget.
* Contributed to 5 Product Development Teams to uncover physician needs and help
define products.
* Initiated and chaired numerous committees, including: Product Planning, Busine
ss Planning, and Research & Technology.
* Created questionnaires for 10 physician advisory reviews and facilitated discu
ssions.
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Kristin Ruffner, Ph.D. / Page 3 of 3
Principal Department Manager, Clinical Operations (1999 - 2000)
Senior Department Manager, Clinical Operations (1997 - 1999)
Senior Clinical Project Leader, Clinical Operations (1994 - 1997)
Created and oversaw global clinical strategies and all phases of clinical studie
s to evaluate implantable pacemakers, external instruments, cardiac pacing leads
and delivery systems and atrial fibrillation devices. Drafted and negotiated cl
inical contracts. Wrote 10+ new job descriptions and competency models. Develope
d 15 new standard operating procedures for clinical studies. Managed project and
department budgets ranging from $200,000 to $5 million. Led 3 global cross-func
tional clinical project teams and supervised clinical departments with as many a
s 40 employees.
* Oversaw 10+ pre-market approval clinical studies spanning up to 300 patients a
t 45 centers in U.S., Canada, Europe, Africa, Latin America, and Australia. Inte
racted with FDA and other regulatory agencies.
* Cut clinical study cycle time in half by spearheading 10 system and process re
engineering projects.
* Streamlined investigator selection process through development of physician pr
ofile system.
* Increased productivity by initiating development and global implementation of
remote electronic data entry system.
* Eliminated need for pre-market approval clinical evaluation of 3 new pacemaker
features by establishing process for conducting clinical feasibility studies us
ing downloadable software.
* Gained FDA acceptance of reduced clinical study scope by initiating and produc
ing matrix identifying bench, animal, and pre-clinical human testing requirement
s on pacemaker with 10 new features.
* Established first physician advisory board for clinical study design reviews a
nd oversaw 10 physician advisory board meetings.
EDUCATION
ST. THOMAS UNIVERSITY, Minneapolis, MN
Master of Business Administration: General Management
UNIVERSITY OF MINNESOTA, Minneapolis, MN
Ph.D.: Biomedical Engineering
UNIVERSITY OF MINNESOTA, Minneapolis, MN
Master of Science: Biomedical Engineering
UNIVERSITY OF TENNESSEE, Knoxville, TN
Bachelor of Science: Biochemistry
PROFESSIONAL AFFILIATIONS
Mentium 100 Mentoring Organization
Life Science Alley
St. Thomas University Alumni Association
COMPUTER SKILLS
MS Word, PowerPoint, Excel, Access, and Project; JD Edwards, ClinDex, eRT, and O
racle Clinical