Title:Kay Baldwin

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Name: Kay Baldwin

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City: Thousand Oaks

State: CA

Zip/Postal Code: 91362

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E-mail: abp5dh@r.postjobfree.com

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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.

805-***-****

abp5dh@r.postjobfree.com

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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