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Clinical Research Manager

Location:
Joshua Tree, California, 92252, United States
Salary:
negotiable
Posted:
April 30, 2018

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Resume:

FLAVIA FERRARI, DVM/PhD

913-***-**** • ac5apz@r.postjobfree.com

Trained veterinarian with 5.5 years of experience in the animal health industry (pharmaceutical and biologicals), well versed in 9 and 21 CFRs and GCP/GLPs

Motivated, ethical, and multi-lingual team player known for superior technical writing, customer service, and communication skills

Lawful Permanent US Resident; native Portuguese speaker; bilingual proficiency in English and conversational in Spanish

EDUCATION

Doctor of Philosophy (PhD) in Veterinary Science, Mississippi State University, Starkville, 2012.

Bachelor’s Degree in Veterinary Medicine (DVM equivalent), Federal University of Vicosa, Vicosa, Brazil, 2007.

PROFESSIONAL EXPERIENCE

CEVA ANIMAL HEALTH, LENEXA, KS 2015–present Clinical Manager – Pharmaceutical Development and Regulatory Affairs

Manager of pre-clinical and regulated clinical research involved in the development of new pharmaceutical products for domestic animal species through licensing with FDA. Responsibilities are as follows (but not limited to):

Participant in meetings with regulatory authorities and author and/or reviewer of regulatory submission documents and meeting materials

Support to assay optimization and validation according to regulatory guidance

Active participant in Ceva drug development quality processes according to all applicable regulatory requirements and guidelines

Technical writing of protocols and study reports and progress report presentation

CEVA ANIMAL HEALTH, LENEXA, KS 2014–2015

Study Monitor – Global Specialty Products R&D

Responsible for clinical research involved in the development of specialty pharmaceutical products for domestic animal species through licensing with FDA

Responsibilities are as follows (but not limited to):

Design and writing of study protocols following GLP/GCPs, specific SOPs, and FDA guidances

Support to assay optimization and validation (ELISAs and RIAs) according to regulatory guidance

Preparation of clinical research technical sections for FDA submission

Monitoring of field and research trials and personnel training

Progress reports in the form of written and oral presentations to Board of Directors

MERCK ANIMAL HEALTH, DESOTO, KS 2012–2013

Associate Principle Scientist – Bovine Parasites, Biologicals R&D

As required by 9 CFR for USDA vaccine approval, responsible for directing the animal and laboratory teams for the research and development of recombinant protein vaccines against cattle ecto- and endoparasites (estimated annual sales: $50 million).

Responsibilities were as follows (but not limited to):

Preparation of clinical research reports for USDA submission

Vast experience as applicant of USDA NCIE permits for import, export and domestic transport of biological materials

Supervision to scientists in the lab (including time reporting, objective settings, performance reviews, and career planning and trainings)

Hands-on assay optimization and validation

Monitoring of field and research trials and farm and lab personnel training

Progress reports in the form of written and oral presentations to Board of Directors

Reference: Dr. Emilio Trigo; +1-913-***-****, ac5apz@r.postjobfree.com

MISSISSIPPI STATE UNIVERSITY, STARKVILLE, MS 2008–2012

Graduate Research Assistant – Laboratory of Infectious Diseases, Department of Basic Sciences

Dissertation involved research of Rickettsia parkeri, a zoonotic agent, transmitted to humans by the Gulf Coast tick, Amblyomma maculatum. My findings were important for the acquisition of NIH R15 grant of almost 0.5 million US dollars by the principal investigator to conduct further studies on tick-borne zoonoses.

Supervision of undergraduate scientists

Design and writing of study protocols, performance of animal trials

Hands-on assay optimization and validation (in-vitro cell-based bioassay, immunoassays, and molecular biology assays)

Hands-on work with animal models and maintenance of ectoparasites colonies

Report progress in the form of written reports and oral presentations

Work in animal models: 2011-2012, Tick challenge in rabbits, sedation, bleeding (marginal ear vein), restraint, necropsy, transmission electron microscopy of ticks. 2009-2010, White-tailed deer fawns rearing from 2 days of age, bleeding (jugular vein),tick challenge, manual restraint, sedation, necropsy of fawns; 2009-2011, Small wild rodents and wild bird trapping with Sherman trap and mist nets, respectively, bleeding and tick challenge on rats, quails and lizards; 2008-2009, Cattle bleeding (jugular vein).

References: Dr. Andrea Varela-Stokes; +1-662-***-****, ac5apz@r.postjobfree.com

Dr. Jerome Goddard; +1-662-***-****, ac5apz@r.postjobfree.com

FEDERAL UNIVERSITY OF VICOSA, Vicosa, Brazil 2004-2007

Research Assistant

Work involved Discovery and Technology research on Dr. Joaquin Patarroyo’s patented synthetic peptide vaccine against cattle ticks and Babebia bovis/bigemina. Responsible for tick challenge models, tick ectoparasiticide resistance tests, maintenance of tick colony, and Immunology, Molecular biology, Parasitology, and Cell culture assays.

Reference: Dr. Joaquin Patarroyo, +55-31-389*-****, ac5apz@r.postjobfree.com

BRAZILIAN DEPARTMENT OF AGRICULTURE LIVESTOCK HEALTH, Belo Horizonte, Brazil 2005

Summer Research Fellowship

Performed routine testing for livestock compulsory diseases. Routine handling of laboratory mice (BSL-2, rabies).

WORKSHOPS AND TRAININGS

2018 Project Management Certificate by Johnson County Community College (ongoing)

2017-2018 Regulatory Affairs in Animal Health Seminar Series by Kansas State Univ. and FDA

2015 USP Veterinary User Forum (April 19th, Olathe, KS)

2015 EU Pharmacopoeia Regulatory Training (March 3-4th, Lenexa, KS)

2013 IICAB/USDA APHIS Veterinary Biologics Training Program (May 20-24th, Ames, IA).

2012-2013 Merck Management Foundation workshop “Setting the Foundations” (Omaha, NE)

2011 NSF workshop “Science: becoming the messenger” (Aug 29th, Mississippi State, MS)

PROFESSIONAL MEMBERSHIPS

American Association of Veterinary Parasitologists (AAVP)

American Association of Swine Veterinarians (AASV)

World Association for the Advancement of Veterinary Parasitology (WAAVP)

American Academy of Veterinary Pharmacology and Therapeutics (AAVPT)

OTHER

Experienced public speaker (list of presentations available upon request)

EndNote, Image J, SAS, Microsoft Office Project, Outlook, Word, Excel, and PowerPoint; Windows 2000/XP/Vista/7, Stratagene MxPro, Softmax, Smartsheet, Google Apps (Gmail, Drive, Docs, etc).

LinkedIn profile: https://www.linkedin.com/in/flaviagferrari/



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