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Senior Veterinary Pathologist

Lawrenceville, GA

your.email@example.com
111-222-3333
www.your-website.com

Summary

Dr. Anderson has over sixteen years experience in preclinical pathology, toxicology and pharmacology research. With a Ph.D. in Molecular Biology and Genetics, a veterinary degree from Oklahoma State University, a residency in anatomic pathology, and board-certified in toxicology, Dr. Anderson has served in management positions in the contract research, pharmaceutical, and biopharmaceutical industries where he has designed, implemented and managed a wide variety of preclinical safety studies. Dr. Anderson has extensive experience in designing in vivo protocols, performing risk analyses and generating the pharmacology and toxicology section of IND supporting regulatory submissions. His therapeutic areas of expertise include Infectious/Parasitic, Central Nervous System, Endocrine/Metabolic, Ophthalmic, Hematology, Respiratory, Biologics and Recombinant Proteins. Dr. Anderson is a member of American Association for the Advancement of Science (AAAS), Society for Toxicologic Pathology (STP), and Society of Toxicology (SOT).

Work Experience

Senior Veterinary Pathologist

Merial Limited,

2010Current

Senior Veterinary Pathology, Global Safety Assessment

Merial Limited, Duluth, GA

2010Current

Provides gross, histopathologic and clinical pathology diagnostic services for preclinical safety studies. Provides preclinical technical leadership in the Discovery Research for opportunity evaluations. Responsible for the planning and supervising of preclinical proof-of-concept/efficacy projects and the facilitation of in vivo and in vitro preclinical safety screening projects of formulations and molecules in discovery, research or pre-development. Manages safety programs within Development Projects programs, authors risk assessments and supports in-line development as requested. Supervises others assigned to projects. Responsible for coordination and maintenance of resource and financial budgets for the preclinical projects involved. IACUC member. 
 
Merial Limited, Duluth, GA (2008 - 2010) 
Preclinical Leader (Director), Global Safety Assessment 
Responsible for the planning and supervising of preclinical proof-of-concept/efficacy projects and the facilitation of in vivo and in vitro preclinical safety screening projects of formulations and molecules in discovery, research or pre-development. These projects represent components of one or more major worldwide pre-development programs. Provides preclinical technical leadership in the Discovery Research for opportunity evaluations. Manages safety programs within Development Projects programs, authors risk assessments and supports in-line development as requested. Supervises others assigned to projects. Responsible for coordination and maintenance of resource and financial budgets for the preclinical projects involved. Provides pathology support. IACUC member.

Preclinical Leader

Merial Limited,

2008 2010

Senior Study Director & Toxicologic Pathologist

Bridge Pharmaceuticals,

2007 2008

Sr. Study Director and Toxicologic Pathologist

Bridge Laboratories, Gaithersburg, MD

2007 2008


Served as Study Director, Pathologist and Clinical Laboratory Animal Veterinarian for GLP and exploratory toxicology and pharmacology studies. Responsibilities included:
  • Managing the conduct of preclinical toxicology studies involving preparation of study protocols and animal use forms, observation of animals throughout study cycle, review of study data for scientific quality, and preparation of final reports.
  • Responding to Quality Assurance audits
  • Communication with study Sponsors.
  • Developing and reviewing new procedures, technologies, and SOPs as required.
  • Interpretation of clinical pathology data and generation of reports.
  • Supervision of Necropsy staff, evaluation of gross lesions, and preparation of reports.
  • Evaluation of histologic slides from preclinical toxicology studies and preparation of reports.
  • Project manager for a major NIH contract.
  • Serve as one of several clinical laboratory animal veterinarians responsible for the medical care of non-human primates, dogs, rats, mice, rabbits, and guinea pigs.

PPD, Inc., Morrisville, NC (2006-2007)
Associate Director, Preclinical Development
Responsible for designing and managing preclinical development programs from early discovery through regulatory submission for internal compound partnering programs as well as client programs. Responsible for identifying required preclinical studies for regulatory submissions, ensuring the preclinical program supports the manufacturing program and the intended clinical program, managing all aspects of the preclinical studies, and for generating the pharmacology/toxicology section of submissions.

Lead and manage PPD Preclinical Programs:
  • Worked as part of project team to develop preclinical development programs and managed those
programs across all laboratories (within and outside of PPD)
  • Reviewed and analyzed preclinical data (toxicology, pharmacology, and drug metabolism data)
  • Prepared preclinical development plans necessary to support intended clinical program and ensured successful IND, NDA (or other regulatory submission)
  • Tracked preclinical projects: track studies and timelines, and metrics
  • Prepared preclinical protocols and reports
  • Worked with multidisciplinary team of scientists (chemists, pharmacologists, toxicologists,
biochemists) to ensure preclinical programs were fulfilling objectives and scientific issues were addressed
  • Prepared pre-meeting packages (e.g., pre-IND packages) and defend preclinical programs to FDA
  • Prepared pharmacology/toxicology sections of INDs
  • Led subgroup meetings and ensured an appropriate communication flow
  • Served as primary PPD contact for Sponsors on preclinical programs
  • Tracked progress and metrics of projects. Maintained current knowledge of status of assigned projects relative to preclinical programs and regularly updated senior management.
  • Tracked finances of preclinical programs and communicated to Finance

Associate Director, Preclinical Development

PPD, Inc,

2006 2007

Principal Scientist I

Talecris Biotherapeutics,

2003 2006

Principal Research Scientist

Talecris Biotherapeutics, Inc, Research Triangle Park, NC

2003 2006

Toxicology, Pathology and Pharmacology)
Designed, implemented and managed preclinical safety studies for new biological entities. Provided histopathology expertise for all preclinical studies.
  • Developed and supervised 3 scientists charged with developing and implementing novel pharmacodynamic and pharmacokinetic studies in various animal species.
  • Provided risk assessments and generated preclinical sections of regulatory documents.
  • Served as preclinical representative on cross-functional drug development teams.
  • Generated a toxicologic risk analysis showing negligible health risk to patients receiving a therapeutic produced by a process associated with a manufacturing deviation. Resulted in release of $30M of product that had been placed on hold.
  • Streamlined an in vivo protocol designed to assess better drug efficacy by increasing through-put 5-fold and decreasing compound requirements 100-fold.
  • Enlisted and consulted with subject matter experts, then designed, implemented, and managed a $4M preclinical development plan for a therapeutic that will be delivered by a novel route of administration.
  • Prepared preclinical sections of regulatory submission documents (e.g., CTDs, INDs, IBs).

Research Fellow in Investigative Pathology & Toxicology

GlaxoSmithKline,

1999 2003

Research Fellow in Molecular Pathology, Safety Assessment

GlaxoSmithKline, Research Triangle Park, NC

1999 2003

Performed an integral function as part of a team formed to evaluate and implement genomic, bioinformatic, and molecular biological techniques for predicting toxicity and understanding mode of toxic action of new chemical entities. Research results were published in 8 manuscripts.
  • Acting as a member of a large cross-functional team, assisted in the design and execution of experiments comparing rat and non-human primate adaptations after acute and subchronic exposure to a class of PPAR agonists.

Postdoctoral Trainee, Cancer Research Program

CIIT Centers for Health Research, Research Triangle Park, NC

1994 1999

Carried out doctoral thesis research on the molecular mechanism of PPAR-agonist-induced hepatocarcinogenesis in rodents. Research led to 7 peer-reviewed publications and 2 book chapters.

Resident in Anatomic Pathology

North Carolina State University, College of Veterinary Medicine, Raleigh, NC

1992 1994

Carried out gross, histologic, and ultrastructural examinations of domestic and laboratory animals.
  • Recognized an internal deficiency for training in comparative pathology. Established connection with the pathology department at UNC medical school and served as the first veterinary pathologist to train in human pathology at that institution.

Visiting Resident in Anatomic Pathology

North Carolina State University, College of Veterinary Medicine, Chapel Hill, NC

1993 1993

Research Associate, Biochemistry

Oklahoma State University, College of Veterinary Medicine, Stillwater, OK

1989 1992

Visiting Researcher, Cell Biology

Oklahoma State University, College of Veterinary Medicine, Houston, TX

1991 1991

Education

Ph.D. in Comparative Biomedical Sciences

North Carolina State University, Raleigh, NC

2001

Anatomic Pathology

North Carolina State University, Raleigh, NC

1994

D.V.M. in Veterinary Medicine

Oklahoma State University, Stillwater, OK

1992

B.S. in Zoology

University of Oklahoma, Norman, OK

1985

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