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Project Management

Location:
New York, New York, 10065, United States
Posted:
May 25, 2010

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Elena Maksimova

*** **** ** ***, *** *A New York, NY 10065 home (212) ***-**** E-

mail:abmrfx@r.postjobfree.com

PhD Scientist: Drug Discovery & Development

. Extensive scientific background and expertise in drug development

(oncology, diabetes, cardiovascular diseases, women's health,

ADHD),

superior knowledge of products, disease state, therapeutic

initiatives

. Extensive experience in scientific/clinical writing

(manuscripts, abstracts,

posters, grants, clinical protocol synopsis, informed consent,

etc.) and

presenting data on specific topics at various meetings, conferences

. Ability to analyze and interpret complex clinical data to prepare

documents,

slides, and papers

. Ability to identify, build and leverage effective partnerships with a

broad network of national, regional and local thought Leaders

(KOLs)

. Direct experience in fostering relationships with top KOLs and

communicating scientific and/or clinical data to healthcare

professionals

. Broad knowledge and cross functional understanding of clinical trial

methodology and logistics: Good Clinical Practices, FDA

regulations,

ICH/GCP guidelines, IND/NDA requirements, Drug Safety, Risk

Management, Pharmacovigilance & Pharmacoepidemiology

. Experience in pharmaceutical competitive intelligence,

pharmaceutical

market assessments through primary and secondary research

(portfolio

analysis, strategic focus, market entry, strategic alliances,

regulatory

strategy and timing, KOL perception analysis, etc)

. Strong project management, analytical and strategic skills, proven

ability

to lead projects and achieve organizational goals

. Outstanding interpersonal/listening skills

. Computer literate; Proficiency in Excel, Word, Power Point, Photoshop,

Microsoft Project 2003, End Note, Outlook, etc.

EXPERIENCE SUMMARY

With a PhD in Biochemistry, I have over 10 years of experience as a

Research

Investigator with a proven record of accomplishment. I am the co-author

and the first author

of 15 manuscripts published in peer- reviewed journals

My background also includes broad knowledge and cross functional

understanding of clinical trial methodology and logistics: Quality

Assurance/ Regulatory Affairs (Good Clinical Practices, Drug Development,

FDA regulations, ICH/GCP guidelines, IND/NDA requirements, Drug Safety,

Risk Management, Pharmacovigilance, Audit, etc) from Temple University

School of Pharmacy and Business Project Management from NYU (after

completing courses in Business Negotiation, Contract & Procurement, and

Risk & Change Management, etc.).

I have recently completed Mini-MBA: BioPharma Innovation Program from

Rutgers University.

My experience includes pharmaceutical competitive intelligence

with established accounts in diabetes, cardiovascular diseases, oncology,

women's health, ADHD, as well as

the performance of pharmaceutical market assessments through secondary and

primary research (by conducting interviews with financial analysts, the Key

Opinion Leaders,

Principle Investigators, and Study Coordinators, etc), including medical

meetings' coverage.

I am currently taking classes toward the Certificate in Intellectual

Property Law from NYU.

PROFESSIONAL EXPERIENCE

? Pharmaceutical strategic competitive intelligence firm

LCN Consulting, The Dunn Group, NJ, PA, NY

2008 - 2010

SAI MedPartners, ORC Guideline

Pharmaceutical account manager/competitive intelligence analyst

. Designed, managed and utilized primary research and secondary data

(oncology, diabetes, cardiovascular diseases, women's

health, ADHD)

to develop final conclusions and actionable client

recommendations

o designing survey questionnaires

o planning strategies for recruiting respondents using

proprietary network and external resources, identified

pre-clinical, clinical and post- marketing study

investigators

o conducting interviews with experts (including physicians,

study coordinators, healthcare policy-makers, medical

directors, financial analysts, etc.)

. Continually monitored the medical environment to sustain expertise in

disease state management and new therapies, competitive

products and features

. Collected and analyzed disease state and technical product

information

at medical congresses

. Analyzed strategic focus, strategic alliances, market entry scenarios,

licensing and partnering, etc. in key emerging markets

. Prepared and delivered all reports including formal in-person

presentations

. Provided recommendations for better business decision making

. Helped maintain and grow business via Existing and Potential Clients

? GE Healthcare Princeton, NJ (part time, on weekends) 2009

- current

Clinical Research Associate

. Monitored the study of investigational medical device for early

detection of breast cancer in accordance with the SOPs to

insure

the integrity per Protocol and GCP guidelines

o assisted in development CRF completion guidelines

o assessed and monitored that investigational devices were

available, handled correctly, stored, documented

o identified areas requiring follow-up and improvement,

recommended corrective action

o completed of the study specific monitoring report

? NYU School of Medicine New York, NY

2004 - 2007

Research Investigator

. Planned, managed and implemented research project's activities to

explore

an anticancer mechanism of cholesterol-lowering drug Lovastatin

(Mevacor)

in non-small cell lung cancer (NSCLC)

. Facilitated scientific exchange between Departments by serving as

an expert

on cancer signal transduction mechanisms

. Assessed, analyzed and proactively developed experiments to

elucidate the

role of microRNAs in non-smal and small cell lung cancers

(NSCLC and SCLC)

. Interacted with other scientists and service groups as necessary

for resolution in order to keep a project going

. Prepared and presented research achievements at international

scientific conferences

? Institute for Cancer Prevention Valhalla, NY

2003 - 2004

Research Investigator

. Independently proposed, designed and executed a project to discover

arsenic carcinogenesis in lung adenocarcinoma (A-549)

. Successfully directed a project team

. Provided leadership on a project that was in development by

coordinating

resources with other groups

? Cornell University Weill Medical College New York, NY 2001

- 2003

Research Investigator

. Designed strategies and conducted experiments to examine the

regulation of Bruton's tyrosine kinase (Btk), the protein which

genetic defects cause the

human disease X-linked agammaglobulinemia (XLA)

. Accelerated discovery of Btk's mechanism by implementing modern

molecular strategies

. Organized training of junior level staff and guided students

? National Institute of Health (NIA) Baltimore, MD

1998 - 2001

Ph.D. Fellow

. Carried out a project to identify the formation of a new complex

between the

wild-type human insulin receptor beta-subunit and molecule X,

a thiol-reactive

membrane-associated protein

. Demonstrated decision-making skills to ensure that the best

decisions were made

. Increased efficiency of a research project by establishing and

developing internal collaborations

. Presented NIH research data at various scientific meetings/

international conferences

HIGHER EDUCATION

? Ph.D. in Biochemistry, Russian Academy of Medical Sciences, Moscow

. Thesis: "The new bioactive insulin analogues" followed by a

Patent

of Russia #2078769.

TRAINING/CERTIFICATIONS

. Clinical Trial Management/Drug Development (FDA regulations,

ICH/GCP guidelines, IND/NDA requirements, Drug Safety, Risk

Management, Pharmacovigilance, Audit, etc.) from Temple

University

School of Pharmacy in progress

. Business Project Management (Risk & Change Management; Contracts,

Procurement & Business Negotiations, etc.) from NYU

. Mini-MBA: BioPharma Innovation Program from Rutgers University, NJ

. Certificate in Intellectual Property Law from NYU in progress.



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