Medical Sales
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Title:Kay Baldwin
**********@*****.***
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Name: Kay Baldwin
Address:
City: Thousand Oaks
State: CA
Zip/Postal Code: 91362
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E-mail: **********@*****.***
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Most Recent Job Title: Director Medical Affairs
Most Recent Employer: Amgen
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Education: PHD
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Desired Salary: Open
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Category: Health Care Management
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Copyright c 1997- Lee Hecht Harrison, Inc.
KATHLEEN BALDWIN
PH. D.
**********@*****.***
SUMMARY
Medical Professional with over 18 years experience in biotech and pharmaceutical
industries. Experience
includes all aspects of medical affairs activities required for product development,
launch and lifecycle
management. Skilled at building successful field and medical communications teams. Known
for
developing lasting professional relationships. Creative problem solver and long-range
planner.
Enthusiastic team player with diverse background and experience.
EDUCATION
Doctor of Philosophy,
Medical College of Ohio, Toledo, OH
Dissertation: Succinylcholine Chloride: Canine Pharmacokinetics, Pharmacodynamics and In
Vitro
Stability in Tissue.
Master of Science,
University of Maryland, College Park, Maryland
Bachelor of Science,
Elmira College, Elmira, New York
PROFESSIONAL EXPERIENCE
Amgen Inc
. Thousand Oaks, CA 2000 - 2009
Director
Risk Evaluation Mitigation Strategy (REMS) Communications Lead (20082009)
Responsible for all communication for newly formed REMS group.
Developed REMS standard operating procedure (SOP) to ensure business compliance
Subject Matter Expert for Health Literacy evaluations and recommendations, to
facilitate patient
understanding of patient product materials to avoid medication adverse events
Led Communications planning for cross-functional medical labeling and ODAC teams for
communications regarding medicinal product benefit to ensure consistent, clear
communications
across company teams
Developed prediction formula for effective and comprehensive communications regarding
product
safety, to promote patient understanding of product benefit / risk profile
Director, Medical Affairs, Denosumab External Relations (Medical Communications) (2005
2008)
Company Representative for Society Corporate Advisory Boards, single point of contact for
all Company
activities to ensure compliance in execution of all business activities. Responsibilities
included: designing
scientific society plans; Opinion Leader contacts, scientific congress planning,
Professional Society
corporate memberships, annual budget, corporate contact, contract execution and
compliance to network
with therapeutic thought leaders.
Developed 11 strategic scientific society engagement plans- ISCD, ASBMR, NOF,IOF, ENDO,
ACR, ASCO, ECTS, EULAR, ACR, and ESMO to provide disease state education on new
therapeutic pathway, establishing priority placement at scientific conferences prior to
product
launch
Developed strategies for congress planning and clinical study initiatives with Opinion
Leaders to
optimize resources and educational opportunities
Secured therapeutic area investigators, speakers, and authors in Oncology and
Osteoporosis by
identifying and networking with Opinion leaders, to increase presence at professional
society
meetings of product and disease state information
Developed and initiated three-year strategic global Denosumab publication plan and
meeting
format to cover three therapeutic areas for preclinical, clinical, global government
affairs,
epidemiology, and registry including planning for 28 congresses annually, providing
consistent
and comprehensive global communications across all indications
K Baldwin 805-***-**** Page 2 of 7
Senior Associate Director, Oncology Medical Affairs (Neupogen/Neulasta & Oncology
Pipeline
Products) (2002 2005)
Built medical communications team for launch of Neulasta and Oncology pipeline products.
Managed
team of 11 oncology medical communications professionals. Participated as clinical expert
with home
office senior management to develop strategies for Neupogen/Neulasta & Oncology Pipeline
business
initiatives.
Led cross-functional teams to develop and execute global publication plans for
Neupogen,
Neulasta, Kepivance, AMG 531, AMG 162, and Panitumumab, enabling development of strategic
publication materials to launch and maintain product lifecycle communications
Developed medical communication tools for $3 billion Neupogen/Neulasta brand & pipeline
products clinical product slide decks, investigator slide decks, DTC materials for
field and
medical professionals, helping to educate health care providers on appropriate use of
product
Provided medical content review to ensure product information accuracy for Legal and
Regulatory
review process
Strategically developed and implemented Medical Communication Commercial Plan with the
Brand team for the launch of Neulasta, supporting the development of key publications for
formulary for product reimbursement
Directed Medical Affairs team to produce and manage compendia submissions, sales force
and
medical liaison training, Opinion leader strategic plan, and medical communications
deliverables
including advisory board content, print materials and media, standardizing the processes
and
improving productivity
Senior Manager, Nephrology Medical Affairs (Aranesp Chronic Renal Insufficiency) (20002002
)
Solely responsible for providing clinical communications strategy for launch of Aranesp
in Chronic Renal
Insufficiency (CRI).
Researched and designed medical education materials on use of Aranesp in Chronic Renal
Insufficiency for educating sales force and other business units on disease state and
current
therapies
Provided clinical training on Aranesp to Medical Liaisons, sales force, government
affairs and
Opinion Leaders, providing first hand accurate product information
Reviewed medical content to ensure product accuracy for all launch materials.
Developed and participated in professional congress plans to support international
medical
meetings therapeutic area updates, competitive intelligence, advisory board planning,
furnishing
accurate compliant information
Received recognition for creating process for Compendia submissions for state Medicaid
applications and VA/DOD formulary, allowing for nation-wide product reimbursement
Glaxo Smithkline
; Philadelphia, PA 1996 - 2000
District Sales Manager
(Los Angeles District) (19992000)
Hired, trained & managed 13 pharmaceutical sales representatives to promote Paxil,
Augmentin,
Bactroban, Relafen, Requip, Engerix B, Havrix, Famvir & Baycol in the Los Angeles
District
(Beverly Hills to Torrance including East and West LA)
Moved the territory up in sales 4 levels in one year
K Baldwin 805-***-**** Page 3 of 7
Manager, Technical Training & Field Continuing Education
19981999
Developed content for annual training materials for 7 launch products and 11 in line
products;
Launch: Hycamtin, Lymerix, Coreg, Avandia, Paxil, Tevetin, & Baycol. In line: Kytril,
Augmentin,
Famvir, Requip, Relafen, Timentin, Androderm, Havrix, Engerix B, Infanrix & Bactroban to
ensure
field product competency
Developed and directed annual September field certification for seven sales forces
Created first company interactive virtual CD training system for product launch to
initiate new
technology for field training, reducing travel expenses and improving convenience
Launched first company continuing education program to differentiate field force,
increasing
product/disease state knowledge and face-time with health care professionals.
Received New Media Technical Excellence award for first company interactive Oncology
virtual
reality cancer training center with Raymond Karson Associates
Senior Oncology Medical Associate, (California, Arizona, Nevada, Hawaii) 1996 1998
Identified & and cultivated new and emerging thought leaders & maintained communication
with
established opinion leaders.
Developed & presented scientific therapeutic area updates to healthcare professionals.
Maintained current knowledge of oncology therapeutics and guidelines by attending ASCO,
ASH,
NCCN, SABCS, & AACR, & utilizing literature searches.
Coordinated regional Medical Education Programs and managed budget to support
educational
grant requests
Identified sites, enrolled investigators & coordinated 14 Hycamtin & Kytril phase 3b/4
clinical
studies
Presented to Regional Managed Care Groups
Worked, as needed, with National Account Managers in assigned region.
Presented clinical data to MDs for formulary decision meetings; City of Hope, UCLA,
USC,
Cedars Sinai, UCI, VA San Diego, VA Los Angeles, Queens, Straub & Tripler Honolulu,
Hawaii,
and the CAC in Hawaii
Assisted in preparation for Oncology meetings and provided booth support.
Attended and presented at regional sales training & POA meetings as needed.
Assisted in preparation and presented at advisory board meetings
ADDITIONAL EXPERIENCE
Clinical Scientist
: Toxicology, Immunology, Special Chemistry, Flowcytometry,
Radioimmunoassay,
Western Regional Reference Laboratory, SmithKline Beecham Clinical Laboratories. Van
Nuys, CA.
Directed 5 departments and managed six supervisors, 60 full time employees, and work
flow for a
24 x 7 reference laboratory for human clinical specimens
Managed $3 million capital and reagent budget
Managed stat laboratory providing results within 4 hours from receipt of sample for
comprehensive drug analysis, therapeutic drug monitoring and chemistry analyses
Provided medical interpretation to MD inquiries regarding laboratory test results
Prepared Clinical Reference Laboratory for CAP and state inspections to maintain
licensure for
CA, NY & FL
K Baldwin 805-***-**** Page 4 of 7
Maintained Laboratory Director Licensure in New York, Florida and California to qualify
site as
Clinical Trials testing laboratory for the Nation
Directed coordination of conversion to a National Standard Database for Nationwide
laboratory
reporting system for entire company.
Received award for process improvement initiatives that significantly decreased lab
costs.
Forensic Toxicology Supervisor, Ventura County Crime Lab, Ventura, CA
Supervised toxicology section of Crime Lab to maintain chain of custody and meet
increasing
case load
Analyzed human specimens for drug content & reported interpretation for legal cases
Provided drug information & training to staff, DA s office & police officers
Testified as Expert Witness in Municipal & Superior courts
Presented annual budget requests to secure required capital equipment and staff to meet
case
work requirements
PROFESSIONAL AFFLIATIONS
U S Bone Joint Decade
American Society of Bone & Mineral Research member
National Osteoporosis Foundation
Endocrine Society
American College of Obstetrics & Gynecology
International Society of Clinical Densitometry
American Association of Clinical Endocrinologists
Pagets Foundation
American Society of Hematology
American Society of Clinical Oncology
American Diabetes Association
Medical Oncology Association of Southern California
Oncology Nurses Society
California Society of Health System Pharmacists
California Association of Toxicologists
Society of Forensic Toxicologists
American Association for Clinical Chemistry
American Academy of Forensic Sciences
PUBLICATIONS AND ABSTRACTS
LECTURES
Outsourcing Considerations for Global publication Planning: ISMPP Annual Meeting, 2005
Amgen Oncology Pipeline: Medical Liaison Training, December, 2004
Hematopoiesis: Corporate Account Manager (CAM) Training, April, 2003
Cancer, Chemotherapy, and Neutropenia: CAM Training, April, 2003
Neupogen: History and Clinical Overview, CAM Training, April, 2003
Neulasta: Discovery and Clinical Overview, CAM Training, April, 2004
Clinical Update for Neulasta and Neupogen, Medical Liaison Training, October, 2002
Risk Models for Evidence-Based Decision Making: proactive Management, (Chemotherapy
Induced
Neutropenia Launch) April, 2002
Darbepoetin Alpha: Clinical Overview, Atlanta Regional Advisory Board, November, 2001
Renal Anemia Management Period, New Hire Training, Amgen, November, 2001
K Baldwin 805-***-**** Page 6 of 7
Managing Iron Balance, New Hire Training, Amgen, November, 2001
Epogen Product Information, New Hire Training, Amgen, November, 2001
Erythrokinetics, New Hire Training, Amgen, November, 2001
Ovarian Cancer: Overview of Diagnosis and Treatment, UCLA, September, 1998
Hepatitis A: Disease Background, Treatment, and Immunization, June, 1998
Small Cell Lung Cancer, An Overview, Straub Tumor Conference, Honolulu, Hawaii, July,
1997
Oral Antiemetic Agents, Santa Barbara Cancer Foundation, September, 1997
Current Studies with Topoisomerase l Agents, Queens Pharmacy Group, Honolulu, Hawaii,
July 1997
Diagnosis and Treatment of Ovarian Cancer, CIGNA, Glendale, California, February, 1997
New Therapies for the Treatment of Ovarian Cancer, Sunrise Hospital conference, Las
Vegas, Nevada,
May, 1997
Ovarian Cancer, an Overview, Straub Tumor Conference, Honolulu, Hawaii, July, 1996
TEACHING APPOINTMENTS
Medical College of Ohio: Pathology Laboratory;
Oncology: Benign and malignant neoplasia, leukemias, lymphomas, atypical lymphocytes,
carcinomas
Hematology; macrocytic anemias, hereditary hemolytic anemias, acquired hemolytic anemias,
Cardiovascular: atherocslerosis, myocardial infarction, valvular diseases of the heart,
hypertension
Respiratory system: respiratory infections
Laboratory Test Interpretation: specificity, sensitivity, prevalence, predictive value
Forensics: Heavy Metals
WORKSHOPS
Legal Aspects of Urine, Blood and Hair Drug Testing, TIAFT & Society of Forensic
toxicologists Joint
meeting, Tampa, Florida, October, 1994
Therapeutic Drug Monitoring for Nursing Home Patients, Continuing Education Workshop for
Long Term
Care Nurses, San Diego, California, September, 1994
Psychotropic Medication and the Need for Laboratory Testing, California department of
Corrections, April,
1993
Tricyclic Antidepressants, California Association of Medical Laboratory Technologists,
October, 1992
Substance Abuse Testing, Illinois Addiction Counselors, May, 1990
Drug Testing Procedures and Results, Ventura County Alcohol Information Counselors
workshop,
January, 1988
Substance Abuse Local Scene, Ventura County Probation Officers, November, 1987
Drug Analyses for Substances of abuse, Ventura County Public Defenders, March, 1987
BOARD CERTIFICATION
K Baldwin 805-***-**** Page 7 of 7
Forensic Toxicology Certificate No 194, American Board of Forensic Toxicology, January,
1993
LICENSURE
Private Pilot, Single Engine, Land, 1985
TRAINING AND CERTIFICATION
State of California, Laboratory Director, September, 1992 (license #00231 File # 39975)
New York State Department of Health, October, 1991 (#880295)
Laboratory Director
Forensic Toxicology
Drug Analysis/Qualitative
Therapeutic Substance Monitoring/Quantitative Toxicology
Endocrinology
Diagnostic Immunology
Drug Recognition Expert, Los Angeles Police Department, October, 1989
Forensic Alcohol Supervisor, State of California, January, 1989
Drug/Alcohol Recognition Training, June, 1986
Intoxilyzer Operator
May 1986
California Health and Safety Training Drug Influence, January, 1986
EXPERT WITNESS
Ventura County Municipal and Superior Courts; 27 appearances as Expert Witness in cases
involving
drugs of abuse
1985-1989
HONORS AND AWARDS
Special Award Recognition: ASBMR Meeting 2008 - Amgen
Sales & Marketing STOCK Recognition Award: Aranesp/Enbrel 2003 - Amgen
Commercialization & Change Management Recognition Award 2002 Amgen
Amgen Development Award: Neulasta launch - 2002
Amgen Development Award: Aranesp Launch Compendia Project- 2001
Pharmaceutical Industry Sales Training Vision Award: Avandia CD-ROM training 1998 SB
Reengineering team leader: SmithKline Beecham Clinical Laboratories Reorganization
-1997
SB stock option award to top 2%: special projects: 1996 SmithKline Beecham
Simply the Best Award: Process Improvement Team lead 1995 SmithKline Beecham (SB)
National Standard Database Conversion: Western Region Project leader
-1994 SB
Who s Who World Book of Women
Outstanding Young Woman of America Award, California
Certificate of Recognition, Sigma Xi, Medical College of Ohio
Magna cum Laude & Emerson Liscum Diven Prize for scholarly work in Biology, Elmira
College
Honors Scholar, Elmira College
Certificate of Academic Excellence, Louisiana State University
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