Chief Medical Officer in NYC NY NJ Resume Evelyn Rodriguez

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					                      EVELYN M. RODRIGUEZ MD, MPH, MBA
                           Mountain Lakes, NJ 07046 / 862-812-2885 / drevelynrodriguez@yahoo.com
                                             http://webprofile.info/erodriguez/

            SVP / CHIEF MEDICAL OFFICER / PUBLIC HEALTH EXECUTIVE
Award-winning medical executive with deep expertise in clinical medicine, epidemiology and health outcomes, medical product
development, pharmaceutical regulatory sciences supporting global pharmaceutical/biotech companies and public health
organizations. Successful at building and leading diverse, high-performance teams that collaborate to achieve aggressive program
goals in epidemiology, pharmacovigilance, and public health. Highly effective at leveraging stakeholder relationships, key
resources, and leadership skills to promote public health, drug development, drug safety, and risk management. Visionary
strategist with proven ability managing regulatory/compliance issues, multimillion-dollar budgets, and drug development for
global drug/biotech companies. Possess unique combination of medical, public health, and business expertise as a licensed, dual-
board physician with both MBA and MPH. Bilingual in English and Spanish.

                External Environment Assessment & Evaluation         Pharmacovigilance / Pharmacoepidemiology
                Medical Regulatory Compliance                        Medical & Clinical Research
                Public Health/ Epidemiology                          Team Leadership & Collaboration
                Strategic Planning & Tactical Execution              Leveraging Stakeholder Partnerships

                                            PROFESSIONAL EXPERIENCE
JANSSEN ALZHIEMER IMMUNOTHERAPY – San Francisco, CA                                                                 2010 – 2011
Subsidiary of Johnson & Johnson dedicated to developing treatments for Alzheimer's disease.
VP, Global Pharmacovigilance & Risk Management
Managed day-to-day operations supporting global pharmacovigilance and risk management programs. Oversaw 20 direct/indirect
reports and $5 million budget. Accountable for all aspects of drug safety studies from overseeing strategic planning and risk
management functions to developing program goals, processes, policies, and procedures. Approved medical safety reviews.
Reviewed all safety documents, clinical trial reports, and risk management plans. Planned safety and risk management activities in
preparation for filing first NDA.

 Led team in gathering and presenting information to alleviate FDA and regulatory concerns worldwide regarding Phase 3
  clinical trial, securing approval to sell first disease modifying treatment for 35 million patients with Alzheimer’s disease.
 Worked closely with contractors to establish blueprint to create Risk Evaluation Minimization (REMS) systems, ensuring
  adherence to drug development milestones in treating Alzheimer’s disease, a projected $10.1 billion market by 2020.
 Achieved inspection compliance with FDA and global regulatory agencies as result of leading departmental effort to rewrite and
  consolidate 20+ documents into nine SOPs as part of recent corporate acquisition.
 Improved inspection readiness and compliance with FDA/global regulatory requirements regarding drug development after
  spearheading implementation of Argus database with related training four months ahead of schedule.

RODRIGUEZ HEALTH CONSULTING SERVICES, LLC – Mountain Lakes, NJ                                        2009 – 2010; 2011 - Present
Health-based consulting firm specializing in clinical risk assessment and management activities.
President
Oversaw daily operations for consulting firm providing global safety surveillance, safety data review, signal detection, and risk
assessment/management services. Planned and coordinated working groups to develop risk management and REMS. Conducted
medical reviews and coding for adverse event case reports and clinical assessments for causality. Prepared summary medical
assessments. Provided medical monitoring, safety review of study protocols, IBs, safety monitoring plans, CSRs, line listings, IND
annual reports, PSURs, and other clinical safety regulatory reports.

 Performed medical review of individual and aggregate cases to enable company to respond to regulatory queries in short
  turnaround time that protected drug labels while safeguarding product availability and patient safety.
 Maintained profitability and maximum patent protection for client products by developing and implementing risk management
  plans to position clients to file NDAs (New Drug Applications) according to milestones.

BAYER HEALTHCARE – Montville, NJ                                                                                    2005 – 2008
Global research-based pharmaceutical company with sales exceeding EUR 16.9 million.
VP, Global Pharmacoepidemiology
Provided pharmacoepidemioiogical, medical, and regulatory executive leadership with oversight for five direct reports including
two student interns. Directed and participated in all safety assessments and risk management for biological and pharmacological
products in post marketing and development phases. Accountable for developing and implementing strategies, program goals, best
practices, and standard operating procedures/processes supporting pharmacoepidemiological studies and risk management plans.
Maintained compliance with applicable regulations. Provided guidance in drug safety, regulatory matters, and life cycle/risk
management.
EVELYN RODRIGUEZ, Professional Experience, Continued…                                                             PAGE 2 OF 3
 Maintained product continuity by devising and implementing strategic staffing plans to provide routine product safety signal and
  medical reviews to regulatory authorities in timely manner.
 Maximized profits as result of closely tracking and managing 5 million euros operating budget and key resources to address
  project/program priorities in meeting regulatory and risk management requirements for product portfolios.
 Saved and positioned company’s cash cow product for market growth after cultivating and maintaining key relationships with
  industry partners, regulatory entities, and scientific colleagues to address company’s worldwide regulatory product concerns.
 Ensured product availability by establishing network of consultants to address pharmacoepidemiological communications and
  risk management needs including organizing and chairing first company-sponsored Epidemiology and Risk Management
  Advisory Boards.
 Increased product earnings and patent protection through design and roll out of risk management plan for new drug indication in
  three weeks time that enabled company to meet its filing milestone.

NPS PHARMACEUTICALS, LLC – Bedminster, NJ                                                                         2004 – 2005
Outsourced-based biopharmaceutical product development company.
VP, Global Pharmacovigilance
Directed all activities related to drug/device safety studies and risk management. Oversaw SOPs, program requirements, medical
safety reviews, clinical trial reporting, and regulatory document documentation regarding drug safety. Performed global safety
surveillance and data reviews. Designed and supervised studies to support products in development and post marketing phases.
Leveraged key relationships to meet regulatory requirements.

 Successfully filed company’s first new drug application on time after setting up and leading department with new staff to
  identify and resolve highly complex pharmacoviligance and risk management issues.
 Shortened submission times for filing company’s first new drug application (NDA) by six months and secured key funding as
  result of directing safety and risk management planning efforts.
 Laid framework for maximizing drug safety through creation of pharmacovigilance agreement between NPS and its European
  marketing partner.
 Spearheaded efforts to implement company’s first safety database to comply with regulatory requirements serving as essential
  component for filing company's new drug application.
 Averted millions of dollars in potential fines by providing company leadership to Data Safety Monitoring Board to ensure
  regulatory compliance and Good Clinical practice for biological drug addressing short bowel syndrome.

NOVARTIS PHARMACEUTICALS, INC. – Basel, Switzerland                                                                2002 – 2004
Multinational pharmaceutical company with annual sales exceeding $41 billion.
VP, Global Pharmacoepidemiology
Planned and led epidemiological studies and evaluations to assess and manage safety risks for products in both development and
post marketing phases. Supervised 15 direct/indirect reports. Defined and aligned departmental strategies with corporate goals.
Evaluated program performance. Served as organizational representative in field of pharmacoepidemiology.

 Counteracted 50% in staff departure and low morale by designing and deploying global staffing strategy that involved hiring and
  training international team across multiple locations, promoting environment of teamwork and mutual trust.
 Safeguarded product investments after planning and coordinating 6 million euros in departmental budgets and key resources
  supporting projects and programs that addressed training and scientific needs of company.
 Boosted firm’s credibility and visibility as result of delivering presentations at international scientific meetings and authoring
  publications in peer reviewed journals.
 Introduced concept of risk management supporting development of several high-profile products including Zelnorm.

FDA (Office of Science & Epidemiology) – Rockville, MD                                                                1998 – 2002
Organization responsible for evaluating safety profiles of drugs available to American consumers.
Director, Division of Drug Risk Evaluation (1998 – 2002)
Served as one of two Division Directors directing drug safety surveillance, epidemiological science, and risk management
activities. Supervised and trained up to 45 staff members. Accountable for post-marketing evaluation of adverse drug reaction
reports, signal generation, industry safety submissions, drug safety evaluations, and follow-up of drug safety issues. Developed,
implemented, and maintained post market drug risk assessment policy, guidance, and interpretations. Created six-month staffing
plan to hire highly-skilled employees to help address multiple drug withdrawals from US market.

 Spearheaded initiative to create new Office of Science and Epidemiology that included forming organizational structure,
  planning promotions, and fully staffing office servicing organization’s drug safety consulting needs for the agency.
 Received “Annual Best Paper Award” for reporting lack of compliance and how physicians interpret labeling recommendations
  in their practice, resulting in creating a sea change in worldwide legislations, regulations, and creation of risk management
  systems Europe and the US (REMS).
 First to propose sentinel drug safety surveillance to scientific and regulatory communities that laid groundwork for FDAAA
  legislation to implement safety monitoring systems, enabling access to data for 100 million people by July 2012.
EVELYN RODRIGUEZ, Professional Experience, Continued…                                                              PAGE 3 OF 3
Acting Chief, Epidemiology Branch (1998)
Managed branch with oversight for conducting epidemiological studies in support of review divisions. Developed and executed
policies associated with post-market drug risk assessment. Managed cooperative agreements for multi-agency epidemiologic
studies to identify risks posed by specific drugs and correlation between adverse reactions and drug usage. Developed business
processes to improve synergy between disciplines. Integrated and supported new group to assess drug safety signals.
 Led efforts to integrate Medical Epidemiologists with Pharmacologists/Drug Safety Evaluators supporting Office of Science and
  Epidemiology to proactively address drug safety issues for entire agency.

HEALTH RESOURCES & SERVICES ADMINISTRATION – Rockville, MD                                                                1995 – 1998
Federal agency for improving access to health care services for people who are uninsured, isolated, or medically vulnerable.
Chief, Program Development Branch (1997 – 1998)
Promoted to provide development of policies and programs to increase number of health professionals entering field from
disadvantaged and minority backgrounds through grants and cooperative agreements. Oversaw four direct reports. Drafted new
program mission statement providing vision for the programs. Administered portfolio of grants and contracts valued at tens of
millions of dollars to colleges and universities for recruitment and retention of hundreds of minorities in health sciences.

Associate Director, Research / Senior Medical Officer (1995 – 1997)
Led HIV/AIDS research studies and assessment of HIV/AIDS health programs. Co-managed and designed multimillion-dollar
SAMHSA/HRSA/NIMH HIV/AIDS Mental Health Services Demonstration Project. Oversaw proposal review for grant program
involving study of youth infected with HIV. Represented Division of Organ Transplantation with United National Organ
Transplantation Network.

 Developed and launched first demonstration grant program to create tailored programs to screen, treat, and provide health
  related services to tens of thousands of adolescents infected with HIV.

                                              PREVIOUS WORK HISTORY
 CDC Epidemic Intelligence Service Officer, Maryland Dept. of Health & Mental Hygiene, Baltimore, MD*                  1993 – 1995
 Medical Officer, National Institute of Allergy & Infectious Diseases, Rockville, MD                                   1989 – 1993
 Pediatric Physician, Kaiser Permanente Medical Group, Rockville, MD                                                   1989 – 2002

                                            EDUCATION / CERTIFICATIONS
   M.B.A., Fairleigh Dickinson University, Madison, NJ
   M.P.H., (Major: Epidemiology), Columbia School of Public Health, New York, NY
   M.D., Harvard Medical School, Boston, MA
   B.S. in Biology, Saint Francis College, Brooklyn, NY
   Certifications: Public Health & General Preventive Medicine, American Board of Preventive Medicine; General Pediatrics,
    American Board of Pediatrics; Medical Boards, National Board of Medical Examiners; Fellow, AAP; Fellow, International
    Society of Pharmacoepidemiology

                                                          TRAINING
    -    Mellon Fellow, Sergievsky Center, Columbia University
    -    Pediatric Resident & Visiting Clinical Research Fellow, Babies Hospital of the Columbia-Presbyterian Medical Center
    -    Pediatric Intern, Children’s Hospital (Boston)

                                               SELECTED PUBLICATIONS
       Rodriguez EM, Boateng CB, Martinez CM. Association of Erectile Dysfunction and Hearing Loss: Confounding by
        Age. Submitted.
       Wysowski DK, Corken A, Gallo-Torres H, Talarico L, Rodriguez EM. Reports of QT Prolongation and Ventricular
        Arrythmia in Association with Cisapride and Food and Drug Administration Regulatory Actions. Am J
        Gastroenterology 2001: 96(6); 1698-1703.
       Cluxton RJ, Zili L, Heaton PC, Weiss SR, Zuckerman IH, Moomaw, CJ, Van Doren H, Rodriguez EM. Impact of
        Regulatory Labeling for Troglitazone and Rosiglitazone on Hepatic Enzyme Monitoring Compliance: Findings from
        the State of Ohio Medicaid Program. Pharmacoepidemiology Drug Safety. 2005; 14: 1-9. Senior Author and
        Principal Investigator, 2006 Annual Award Winner for Best Paper.
       Rodriguez EM, Staffa, JA, Graham DJ. The Role of Databases in Drug Pharmacoepidemiology Drug Safety. 2001
        Aug-Sep; 10(5); 407-10.

				
DOCUMENT INFO
Description: Evelyn Rodriguez is an award-winning medical executive with deep expertise in clinical medicine, epidemiology and health outcomes, medical product development, pharmaceutical regulatory sciences supporting global pharmaceutical/biotech companies and public health organizations.