JAN MICHAEL KITZEN 325 Sonnet Lane - Collegeville, PA 19426 - 610.489.

4965 - jk
378d38@westpost.net
PROFESSIONAL QUALIFICATIONS
Driven and detail-oriented professional with over 20 years of experience in lead
ing clinical research, providing medical and scientific support for pharmaceutic
al products and developing unique approaches to creativity, knowledge acquisitio
n, problem solving, and improving efficiency. Possesses outstanding organizatio
nal, program development and management, and written and oral communication skil
ls along with a successful track record of promoting teamwork and collaboration
from both internal groups and external partners. A proven leader and medical in
formation specialist who is familiar with various software applications used in
the medical industry. Additional areas of expertise include:
Regulatory Compliance - Research & Development - Parenteral Product Compounding
- Legal Support & Consulting
Team Facilitation - Presentations - Data Analysis & Interpretation - Training -
Management - Quality Assurance
Policy & Procedure Development - Proposal Preparation - Event Planning - Writing
(Medical & Marketing)
EDUCATION & LICENSES
Ph.D. in Pharmacology, THE UNIVERSITY OF IOWA MEDICAL SCHOOL (Iowa City, IA)
B.S. in Pharmacy, TEMPLE UNIVERSITY SCHOOL OF PHARMACY (Philadelphia, PA)
Iowa License #14235 (expiration date: 05/2010) - Pennsylvania License #RP04130
0R (expiration date: 09/2010)
SELECT CONTRIBUTIONS
* Played a key role in saving Wyeth Pharmaceuticals significant costs (hundreds
of millions) and time for products involved in litigation; increased sales of ma
rketed products; and enhanced productivity in Global Medical Communications-Neur
oscience support. Worked directly with health care professionals to answer ques
tions regarding Wyeth's key neuroscience products such as Effexor XR(R) (venlafa
xine) and Pristiq(R) (desvenlafaxine).
* Successfully provided medical and scientific information to health care profes
sionals, including physicians, nurses, and pharmacists. Operated a medical info
rmation booth at a major medical meeting for Wyeth's neuroscience products; revi
ewed and collected comments related to labeling and patient information.
* Organized and co-hosted several large scientific meetings, with 100 to 200 att
endees; planned the logistical needs of the meetings. Arranged for the publicat
ion of presentations at a meeting as a Guest Editor for Drug Development Researc
h.
* Served as team leader for a New Drug Application (NDA); managed and coordinate
d interdepartmental personnel efforts required for NDA preparation. Authored th
e complete pharmacodynamic and pharmacokinetic portions of the NDA.
* Prepared numerous documents, including scientific reports, clinical study repo
rts, white papers, scientific publications, regulatory writing, standard operati
ng procedures, legal documents, and marketing support materials, over the years.
* Designed and developed several experimental models of cardiovascular disease f
or the purpose of discovering and developing new chemical entities for the treat
ment of hypertension, myocardial ischemia, and coronary thrombosis.
PROFESSIONAL HISTORY
SQA PHARMACY SERVICES (Philadelphia, PA) March, 2010 to Present
Temporary Staff Pharmacist-Retail Pharmacy;Enters prescriptions into the compute
r system; fills prescriptions, verifies prescriptions filled by pharmacy technic
ians, and facilitates the successful and accurate dispensing of medication. Con
tacts health care providers and insurance companies as required for filling pres
criptions. Counsels patients on the appropriate use of medications.
WYETH PHARMACEUTICALS - acquired by Pfizer (Collegeville, PA) 2006 to 2009
Principal Scientist / Associate Director-Global Medical Communications (Neurosci
ence)
Summarized key medical articles related to Wyeth neuroscience products for distr
ibution to clinicians, company executives, and global affiliates. Prepared and
updated (according to FDA changes) scientific response letters and product dossi
ers for health care professionals. Created documents, slides, and other materia
ls for the launch of a new antidepressant.
* Created two new databases to support future neuroscience products; updated and
supervised the proper maintenance of literature databases, both hard copy files
and electronic databases. Contributed to related training material development
.
* Performed critical analysis of toxicology literature as it pertains to the saf
ety of antidepressants in support of Wyeth's products in Great Britain. Created
a database that included ~100 central nervous system drugs and how the Fatal To
xicity Index (FTI) parameter is not always a reliable predictor of human toxicit
y.
* Recognized with the "Exceptional Achievement Recognition Productivity" (team)
award for outstanding contribution to the Global Medical Affairs Neuroscience Te
am in 2009.
WYETH RESEARCH (Collegeville, PA) 1997 to 2005
Director-Clinical Science, 2005 / Associate Director-Clinical Science, 2001-2004
Assistant Director-Clinical Science, 1998-2000
Recruited to a newly formed task force, the Clinical Science Division, which was
responsible for providing all scientific, clinical, and literature support to d
efend the company in three drug product injury litigation cases. Created medica
l information databases for use in product-injury litigation cases (different pr
oducts: drug #1, #2, and #3). Produced summary documents, white papers, and lit
erature extracts along with tables of data for use by external counsel and an ex
ternal panel of experts. Performed critical evaluations of plaintiff's science.
Supervised team members in information gathering and ensured all documents wer
e scientifically accurate. Attended scientific meetings and prepared detailed t
rip reports to disseminate information to other members of the clinical science
division as well as external counsel. Assisted in preparing class action docume
nts.
* Greatly reduced the time required to identify important information by creatin
g searchable literature databases.
* Saved the company (and other companies) hundreds of millions of dollars in pot
ential injury claims by hiring a pharmacokineticist and providing sufficient evi
dence to convince the court judge that much of the plaintiff's science was inadm
issible in court (Drug #3)-discredited several scientific papers used by plainti
ff expert witnesses.
* Minimized the company's financial obligations (Drug #2) through efforts that l
ed to the decision by the court to deny class action status for this particular
drug.
* Helped identify fraudulent claims through efforts of translating the final cou
rt-approved version of the class action suit language into algorithms-allowing a
ll submitted cases to be analyzed by computer (Drug #1).
WYETH-AYERST RESEARCH (Radnor, PA) 1995 to 1997
Scientific Writer
Authored clinical study reports required for the submission of New Drug Applicat
ions (NDA). Prepared drug safety updates and investigator drug brochures. Coor
dinated efforts and prepared sections of NDAs. Planned international collaborat
ions between Wyeth, USA and affiliates in Europe to meet corporate deadlines. A
ssisted in new software implementations.
* Functioned as the project leader for preparing the zaleplon (Sonata(R)) NDA; s
cheduled meetings and assigned deadlines to multiple therapeutic divisions to co
mplete all required documents. Successfully met all deadlines related to the su
bmission of two New Drug Applications, for Sonata(R) and Effexor XR(R).
RHONE-POULENC RORER (Collegeville, PA) 1991 to 1994
Section Manager, Cardiovascular Biology
Managed two laboratories involved in discovery and development of new drugs for
the treatment of hypertension and myocardial ischemia. Developed new experiment
al models for preclinical evaluation of new chemical entities. Trained laborato
ry personnel. Ensured compliance with FDA regulations. Analyzed experimental d
ata for study reporting.
* Generated significant cost savings by learning new models of ischemia (that us
ed small animals) from colleagues at local medical schools. Also developed and
performed new assays to support ischemia studies as well as developed and valida
ted alternative methods for measuring regional blood flow in collaboration with
researchers from the University of Pennsylvania School of Medicine.
Additionally appointed as an Adjunct Associate Professor of Pharmacology at Temp
le University Medical School from 1990 to 2000; and reappointed in 2008.
Also employed in various pharmacist (temporary, intern, and extern) roles at Sou
theastern Pennsylvania Veterans Center, Integrated Pharmacy Systems, Medical Col
lege Hospitals, Elkins Park, Medical College of PA, Walter's Pharmacy, Somerset
Medical Center, and Rolling Hill Hospital.
Prior to 1991, served as a Research Scientist (Wyeth-Ayerst Research), Research
Fellow (University of Michigan), and Clinical Research Associate, Research Assoc
iate, and Senior Research Pharmacologist (Hoechst-Roussel Pharmaceuticals).
AFFILIATIONS
Mid-Atlantic Pharmacology Society (MAPS) - Executive Secretary (2009-Present), C
ouncilor (1998-2008), Treasurer, Vice President, and President (1993-1998); Temp
le University School of Pharmacy-Alumni Board of Directors - President (2010-201
2), Vice President (2008-2010), Chairman-Awards Committee (2003-2008); American
Pharmacists Association - Member (1995-2009); American Society for Pharmacology
and Experimental Therapeutics (ASPET) - Member (1985-Present)