Preclinical Researcher

Calypso® Medical Technologies, Inc.

At Calypso® Medical, innovation is our passion. We have created the first in a series of innovative products destined to advance the science of radiation therapy treatment for cancer specialists and their patients. And that's just the beginning. At Calypso® Medical, located in downtown Seattle, Washington, we are proud of our technical excellence, but most importantly, we are committed to making a difference in radiation therapy.

Preclinical Researcher

Lead preclinical studies to generate safety and performance data for medical device in support of product development, regulatory applications, and marketing needs.

ESSENTIAL FUNCTIONS / MAJOR RESPONSIBILITIES

Responsibilities include, but are not limited to: Manage all aspects of preclinical program. Develop preclinical strategy, plan, and protocols for in vitro, in vivo animal, and cadaveric studies to evaluate device performance, and safety, and biocompatibility for product development, regulatory submissions, and marketing needs. Select appropriate models and methods to be used. Evaluate and select contract research laboratory. Negotiate study costs. Act as liaison with lab and attend procedures. Analyze data, prepare reports, and generate abstracts and presentations from study results. Assist in preparing the sections of regulatory filings related to the study results and device usage. Interface with medical professionals during protocol development and data review. Ensure studies are conducted per schedule and within budget. Perform literature search to support protocols.

SECONDARY RESPONSIBILITIESFollow all company safety policies and procedures while ensuring quality work. Handle changing priorities and other duties as required.

SCOPE OF WORKOperates within some standard guidelines, but must engage in some independent decision-making. Responsible for own work products. Errors that are not quickly detected and rectified could have a significantly adverse effect on the quality of the study data. Works closely with other staff in Clinical Affairs, and will staff from Engineering and other departments. Receives general supervision.

MINIMUM REQUIREMENTSPhD or MS in life sciences, health sciences or equivalent degree/experience. Minimum 5 years experience in medical device industry. Experience with in vivo studies involving large animals in industry research setting. Ability to travel in support of the preclinical activities. Ability to follow and implement policies and procedures required of this position.

SKILLS, ABILITIES AND OTHER REQUIREMENTSStrong understanding of scientific principles. Strong project management, documentation, and organizational skills. Excellent analytical skills. Excellent knowledge of MS Word and MS Excel. Detail and accuracy oriented. Strong verbal communication skills and effective writing skills. Successful history in a team-oriented environment yet able to work independently.

PREFERENCES

Experience with radiation therapy and/or oncology. Experience with device in vivo biocompatibility testing. Experience with contract research laboratories. Experience working with external collaborators at universities and hospitals. Small company / start-up experience or work in a highly flexible environment desirable.

JOB CONDITIONS

Travel: 20% on average.

SUPERVISION

Total number of individuals reporting into this position:
Exempt ____0___ Non-Exempt ___0____

If interested, please apply at www.calypsomedical.com/careers
Calypso Medical Technologies, Inc. is an Equal Opportunity Employer





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