General Summary:
American Preclinical Services (APS) is a privately held Contract Research Organization
(CRO) located in the Minneapolis metro area. APS performs preclinical research
for companies developing medical devices, biotechnology, and pharmaceuticals.
APS conducts GLP safety studies, feasibility research, and training/educational
programs in various therapeutic areas including: cardiovascular, pulmonary,
urogenital, neurovascular, and endovascular.
APS is recruiting a Veterinary Pathologist to join our
team. A DVM (or equivalent degree), completion of formal training
in veterinary pathology, creative thinking, strong interpersonal communication
and problem solving skills, and dedication to scientific excellence are
essential prerequisites. Certification, or eligibility for certification
as an anatomic pathologist by the ACVP, ECVP, or equivalent bodies, advanced
training or degrees in a relevant discipline, training or experience in
pathology of laboratory animals, medical devices, toxicology, biotechnology
research, or drug development are desirable.
The Veterinary Pathologist position will be a key member of the team responsible
for building and maintaining a full service Pathology Department in collaboration
with the current Manager of Pathology Services.
Major responsibilities will include: interpretation of gross, microscopic
and clinical pathology data from safety and efficacy studies of novel medical
devices, medical device combination products and novel drug and energy
delivery systems; design and reporting of investigative, mechanistic, and
regulatory preclinical studies; evaluation of targets and animal models. The
Pathologist at APS will contribute to the feasibility evaluation and development
of devices and systems in multiple therapeutic areas focusing on, cardiovascular
diseases, oncology, urogenital, and airway diseases and syndromes,
The Pathologist will collaborate with client engineers, biologists, medical
professionals, and other scientific specialists to understand the mechanisms
responsible for pre-clinical safety findings and quantify the observations
for performance of devices and delivery systems in feasibility- through
GLP-studies in preparation for product registration.
Duties and Responsibilities:
- Serves as Study Pathologist for on-going safety studies conducted in
compliance with FDA and other national and international regulatory agencies
- Performs diagnostic pathology services involving laboratory animals,
writing pathology reports, and reviewing of pathology services.
- Attends department and company meetings; prepares, reviews, and revises
SOPs and protocols.
- Engages in research to develop techniques for diagnosing and identifying
pathological conditions.
- Assists in training department personnel in gross pathology and histology
processing. providing guidance based on client goals, organizational
goals, and company policy.
- Devises and directs use of special stains and methods.
- Counsel clients regarding appropriate study designs and animal models
for their research needs.
- Work in conjunction with the Vice President of Regulatory Compliance
and Chief Scientific Officer to develop and maintain study integrity
and GLP compliant processes.
- Assist in the coordination and prioritizing of client research.
- Conduct briefings and technical meetings for internal and external
representatives.
Minimum Education, Experience, and Skills:
The individual will have a degree in veterinary medicine and be board certified
in anatomic pathology by the American College of Veterinary Pathologists
(ACVP), the European College of Veterinary Pathologists (ECVP), or equivalent
bodies. Candidates who have recently completed a residency program and
have passed at least two parts of the certification examination may be
considered with a contingency agreement that they will pass the certification
examination within two years.
OTHER ATTRIBUTES DESIRABLE:
- MS or PhD and/or research experience or training in medical device
pathology, or pathobiology is an asset.
- Experience in medical device design and utilization within a biomedical
products company is desirable.
- 3+ years of medical device experience with a broad knowledge of animal
models (swine, sheep, rabbits, rodents, and canine).
- In-depth knowledge of GLP regulations and FDA medical device preclinical
guidance documents is an absolute requirement.
- Competent statistical skills.
- Demonstrated project management skills and analytical skills.
- Demonstrated skill in scientific writing as evidenced by scientific
publications and/or successful medical device regulatory submissions.
APS offers excellent benefits including a competitive salary, medical,
dental, short and long-term disability and 401(k). We operate on
a Paid Time Off (PTO) system to allow for vacation flexibility.
EOE
Contact Laura Peacock (lpeacock@apsemail.com)
or 763-717-7990 ext 2033).
Please refer to the ACVP listing upon inquiry.
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