Natalie Elizabeth Goldberger, PhD
Atlanta, GA 30350
*************@*****.***
http://www.linkedin.com/pub/natalie-goldberger/12/b36/7a4
. Highly accomplished and results-oriented medical research PhD scientist
with over 10 years of experience in scientific research and medical
communications seeks to apply her impressive clinical research background
and exceptional critical thinking skills as a Medical Writer.
AREAS OF EXPERTISE, CORE COMPETENCIES
. Medical Writing Skills:
. Wrote four needs assessment grants covering such topics as
immunotherapy, metastatic melanoma, triple-negative breast cancer
(TNBC) and ER-positive (ER+) breast cancer.
. Wrote eight high-level executive summaries for national advisory
boards capturing the clinical development highlights within the
treatment landscape.
. Published eight peer-reviewed manuscripts on original preclinical
oncology research.
. Knowledge of biomedical databases, Boolean logic/operators, medical
terminology and basic statistical/clinical concepts.
. Superb data interpretation and medical writing skills, including
grammatical, editorial, and proofreading skills.
. Regulatory Affairs Skills:
. Regulatory Affairs Certificate: Pharmaceuticals from the Regulatory
Affairs Professional Society (RAPS).
. Member of the Regulatory Affairs Professional Society (RAPS).
. Medical Research Skills: Over 10 years preclinical research experience
identifying and validating cancer biomarkers using animal models combined
with high-throughput genetic profiling techniques.
. Leadership Skills: Independently led five cancer research projects to
successful conclusion while establishing productive collaborations and
mentoring a number of colleagues.
. Teamwork Skills: Worked effectively within a 15 person cross-functional
team structure to produce a high impact healthcare report for the
Secretary of Defense.
PROFESSIONAL EXPERIENCE
Associate Director, Educational Development, Medical Affairs
Imedex, LLC (Atlanta, GA)
October, 2014 - January, 2015
Job Description: Lead the development of scientific and clinical content
for selected educational programs, liaising with chairpersons and/or
thought leaders as instructed. The role involved gathering and evaluating
the necessary clinical and scientific information in the marketplace for
development into successful medical education programs.
Primary Responsibilities:
. Translated complex scientific/clinical information regarding concepts and
directions in patient care, unmet medical needs and research
opportunities within therapeutic areas into educational programs.
. Wrote and developed needs assessments for educational medical grants,
including editing final grant requests, and developing original content.
. Traveled to and participated in proprietary medical conferences to attend
lectures, cultivate key relationships and oversee program-specific
operations.
Natalie E. Goldberger, PhD (Page 2)
. Maintained awareness and enforced implementation of FDA, AMA, ACCME and
other relevant regulations.
Medical Writer, Medical Communication
TRM Oncology (Atlanta, GA)
October, 2013 - July, 2014
Job Description: Responsible for the creation, delivery and execution of
scientific/clinical content within client-sponsored Advisory Boards and
Steering Committees attended by KOLs, TLs, and HCPs. Projects were
successfully executed for such clients as Bayer, Novartis, Celgene, Incyte,
and AstraZeneca.
Primary Responsibilities:
. Assisted in the creation of balanced and objective scientific/clinical
oncology presentations delivered by KOLs and pharmaceutical clients at
national advisory boards and other approved meetings.
. Worked effectively independently and within cross functional teams,
including internal/external networking, to complete client projects in a
timely and productive manner.
. Remained abreast of the current literature, therapeutic issues and
treatment landscape related to oncology pharmaceutical agents.
. Traveled extensively to manage and document the
scientific/medical/clinical content presented at national advisory boards
and steering committee meetings.
. Applied knowledge of treatment guidelines (e.g., NCCN, ASCO, ASH, and
ESMO) and clinical research processes to verify and supplement medical
communications content.
Healthcare Data Analyst
Dynamics Research Corporation (Arlington, VA)
November, 2012 - October, 2013
Job Description: Collected program effectiveness information (e.g.,
funding, staff) from 167 psychological health programs to produce a high
level summary report for the Office of the Secretary of Defense (OSD)
Postdoctoral Research Fellow, Biomarker Discovery in Breast Cancer
National Institutes of Health (Bethesda, MD)
National Cancer Institute, Laboratory of Cancer Biology & Genetics
April, 2008 - April, 2012
Research Focus: Identification of microRNA associated with breast cancer
tumorigenesis and metastasis
Research Assistant, Biochemistry of the Androgen Receptor
Ohio State University (Columbus, OH)
College of Pharmacy, Biophysics Department
June, 2002 - April, 2008
Research Focus: Identification of the molecular mechanisms driving
selective androgen receptor tissue-selectivity
Biologist, Biomarker Discovery in Breast and Prostate Cancer
National Institutes of Health (Bethesda, MD)
National Human Genome Research Institute, Cancer Genetics Branch
July, 1999 - June, 2002
Research Focus: Identification of prostate cancer and breast cancer
progression biomarkers
Natalie E. Goldberger, PhD (Page 3)
Clinical Research Assistant, Clinical Mutation Identification
Georgetown University Medical Center (Washington, DC)
Institute for Molecular and Human Genetics
July, 1998 - June, 1999
Research Focus: Identification of mutations and polymorphisms in genes
MLH1 and MSH2
MEDICAL WRITING
. Wrote four needs assessment grants on immunotherapy, metastatic melanoma,
triple-negative breast cancer (TNBC) and ER-positive breast cancer.
. Wrote the executive summaries for 8 national advisory boards focused on
the development and use of clinical oncology agents
. Wrote the data analysis section of the Psychological Health Initiative
report for the Office of the Secretary of Defense (May 2013)
. Wrote the After Action Report on the Psychological Health Initiative for
the Defense Centers of Excellence (DCoE)
. Medical writer for the Office of Intramural Training and Education, NIH
(2011 - 2012)
. Scientific writer for NIH Catalyst, Intramural Scientist Publication, NIH
(2009 - 2012)
MEDICAL PRESENTATIONS
. Presented research results at the AACR: Noncoding RNAs and Cancer Meeting
(January 8-11, 2012)
Invited guest speaker for the Models of Human Cancers Consortium (MMHCC)
meeting (June, 2011)
. Presented research results at the NIH Research Festival (October 24-28,
2011)
. Presented research results at the American Association of Cancer Research
(April 2011)
. Presented research results at the NIH Research Festival (October 5-6,
2010)
. Presented research results at the MRS-AACR Joint Conference on Metastasis
and the Tumor Microenvironment (September 12-15, 2010)
. Invited guest speaker for the Ohio University Physics Program (January
2007)
. Presented research results at the OSU Molecular Life Sciences Symposium
(May 2007)
. Presented research results at the OSU College of Pharmacy Research Day
(May 2007)
. Presented research results at the Endocrine Society's 88th Annual Meeting
(June 2006)
. Presented research results at the American Association of Cancer Research
(April 2002)
LEADERSHIP SKILLS
. Clinical content lead for The 17th Annual Symposium on Anti-Angiogenesis
and Immune Therapies for Cancer conference (February 2015)
. Clinical content lead for an advisory board on ovarian cancer (June 2014)
. Clinical content lead for three advisory boards on polycythemia vera
(January - May 2014)
COMPUTER AND STATISTICAL SKILLS
. Solid computer skills including proficiency with Microsoft Word, EndNote,
Outlook, PowerPoint, and Excel.
. Scientific and Statistical Applications: Partek Genomics Suite,
Ingenuity Pathways Analysis, GraphPad Prism, Sequence Navigator, BLAST,
GenBank, SEQUEST
Natalie E. Goldberger, PhD (Page 4)
EDUCATION
Regulatory Affairs Certificate: Pharmaceuticals
Regulatory Affairs Professional Society (RAPS)
Covered such topics: GCP/GLP/CMP, US Pharmaceutical Regulations, US
Clinical Trial Process, Global Regulatory Strategy, IND, CTD and NDA
PhD, Biophysics Ohio State University Columbus, OH
BS, Biochemistry University of Delaware Newark, DE
PUBLICATIONS
1. Bai L, Yang H, Hu Y, Doran A, Goldberger N, NCI Sequencing Core, Lee M,
Keane T, Pandolfi PP, Hunter KW. An integrated genome-wide systems
genetics screen for breast cancer metastasis susceptibility genes.
Submitted to Nature.
2. Faraji F, Hu Y, Wu G, Goldberger NE, Walker RC, Zhang J, Hunter KW. An
integrated systems genetics screen reveals the transcriptional structure
of inherited predisposition to metastatic disease. Genomic Research
2014; 24:227-40.
3. Hu Y, Bai L, Geiger T, Goldberger N, Walker RC, Green JE, Wakefield LM,
and Hunter KW. Genetic background may contribute to PAM50 gene
expression breast cancer subtype assignments. PLoS One 2013; 8:e72287.
4. Goldberger N, Walker RC, Kim CH, Winter S, and Hunter KW. Inherited
variation in miR-290 expression suppresses breast cancer progression by
targeting the metastasis susceptibility gene Arid4b. Cancer Research
2013; 73:2671-81.
5. Goldberger N, Hunter KW. A systems biology approach to defining
metastatic biomarkers and signaling pathways. Wiley Interdisciplinary
Reviews: Systems Biology and Medicine 2009; 1:89-96.
6. Bisson WH, Cheltsov AV, Bruey-Sedano N, Lin B, Chen J, Goldberger N, May
LT, Christopoulos A, Dalton JT, Sexton PM, Zhang XK, and Abagyan R.
Discovery of antiandrogen activity of nonsteroidal scaffolds of marketed
drugs. PNAS 2007; 104:11927-32.
7. Mousses S, Bubendorf L, Wagner U, Hostetter G, Kononen J, Cornelison R,
Goldberger N, Elkahloun AG, Willi N, Koivisto P, Ferhle W, Raffeld M,
Sauter G, and Kallioniemi O-P. Clinical validation of candidate genes
associated with prostate cancer progression in the CWR22 model system
using tissue microarrays. Cancer Research 2002; 62:1256-60.
8. Rozenblum E, Vahteristo P, Sandberg T, Bergthorsson JT, Syrjakoski K,
Weaver D, Haraldsson K, Johannsdottir HK, Vehmanen P, Nigam S, Goldberger
N, Robbins C, Pak E, Dutra A, Gillander E, Stephan DA, Bailey-Wison J,
Hank Juo S-H, Kainu T, Arason A, Barkardottir RB, Nevanlinna H, Borg A,
and Kallioiemi O-P. A genomic map of a 6-Mb region at 13q21-q22
implicated in cancer development: identification and characterization of
candidate genes. Human Genetics 2002; 110:111-21.
9. Allander SV, Nupponen N, Ringner M, Hostetter G, Maher GW, Goldberger N,
Chen Y, Carpten J, Elkahloun AG, and Meltzer PS. Gastrointestinal
stromal tumors with KIT mutations exhibit a remarkably homogeneous gene
expression profile. Cancer Research 2001; 61:8624-8.[pic]