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IVD Pathology Director

Apply Share Job ID 1301 Category Clinical Operations Job Location Geneva, Genève Posted Date 04/19/2019

Overview:

Genomic Health has a bold mission to transform cancer treatment decisions and outcomes by delivering clinically actionable diagnostic tests to physicians and patients around the world. Having served more than 1 million patients while saving healthcare systems around the world billions of dollars to-date, Genomic Health has pioneered a life, changing the industry and is seeking an IVD Pathology Director to help shape its next frontier.

The company is based in Redwood City, California with International headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com.


The Role

We are seeking an exceptional Pathologist with a proven industry track record of commercialization of in-vitro diagnostic assays and pathology education to join our Development Oncology & Pathology Organization. Training in surgical pathology is required and molecular pathology experience is preferred. Experience in medical education of pathologists and clinical laboratories supporting their use of IVD products is required. Experience with international quality standards and regulations, including but not limited to: ISO 13485, ISO 15189 and applicable local requirements is required.

Reporting to the Vice President of Development Oncology and Pathology, the IVD Pathology Director will be based in Geneva, Switzerland and work with the Senior Director of Global Applications and the Global Assay Support Team based in Redwood City. They will be work with Global Applications in the design, development and deployment of the pathology training program and the supporting pathology and medical training materials. The successful candidate will also partner with the GHI Field Applications Support Team in Europe to provide pathology-related support. He/She will lead pathology customer training for labs using GHI's IVD products to produce clinical diagnostic results for cancer patients. The candidate will support commercial activities including medical education regarding the IVD device and Oncotype assays and will provide medical expertise and support to the GHI International Team in Geneva including Customer Service, Commercial Operations, Global Sales and Marketing and Medical Affairs to support Genomic Health's IVD product(s). The Pathologist will also develop professional relationships with pathologists and biologists within countries in which Oncotype IVD products and services will be distributed. They will develop an expert understanding of the Redwood City, CA Clinical Laboratory Operations (LDT) with attention to pre and post-analytical support provided by GHI Pathology.

The stringent quality requirements and interactive nature of the work requires excellent attention to detail, effective written and verbal communication skills in English, and commitment to education, scientific writing and public speaking. The IVD Medical Director must be able to work both independently and collaboratively in a team environment, fostering excellent communication and teamwork. The IVD Medical Director will be located in Geneva, Switzerland following training in Redwood City, CA. Additional languages including German and French are preferred.

This person will have completed a residency and/or fellowship in Pathology with at least 12 years expertise including residency and fellowship training and a minimum of 6 years of industry experience in molecular diagnostics products (including assays, software, and instrumentation), preferably in oncology or in academics for a minimum of 6 years.


RESPONSIBILITIES / DUTIES:
Provide highest quality professional global Medical & Pathology services for the GHI International Team in Geneva
· Support the Genomic Health Global Assay Support Team in the development of the pathology training certification program and pathology and medical training materials
· Support GHI Field Applications Support Team in Europe by leading and providing pathology customer training
· Develop and manage relationships and communication with European key opinion leaders regarding GHI IVD product(s)
· Partner with International Customer Service in Geneva by training GHI Customer Service and Field Applications Support staff for customer medical and pathology queries and call backs regarding all medical questions related to GHI IVD products and ensuring completeness of records and appropriate follow up for all customer complaints regarding pre- and post-analytical issues.
· Provide medical and pathology expertise to support GHI IVD Products to the GHI International team including Customer Service, Commercial Operations, Global Sales and Marketing and Medical Affair
· Support and train Medical Affairs and Customer Service for IVD product launch in relevant analytical and clinical validation study results data and clinical utility, health economic and post-market studies
· Support Medical Affairs, Sales and Marketing and Clinical Pathology throughout the post-market IVD product life cycle when Medical or Pathology input is required, including in the development of the educational slide decks, sales materials, speaker events, Speaker Training Programs, and Advisory Boards
· Collaborate in writing IVD related abstracts, presentations, manuscripts and study reports


QUALIFICATIONS:

· M.D. and board-certified in Anatomical and/or Clinical Pathology
· Greater than 12 years of experience in Pathology including
- Greater than 6 years of experience in Industry with IVD experience including medical IVD education for pathologists
· Strong verbal and written communication skills in English
- Team, project or committee leadership experience required
- Highest level interpersonal and communication skills and ability to work as a collaborative and open team member are essential
· Flexible with changing methods and technologies
· Capable of innovative and proactive approaches in identifying new opportunities to refine and improve operations
· Capable of leading and building productive cross-functional collaborations both within and external to Genomic Health
· Able to integrate and apply feedback in a professional manner
· Fluency in English and proficiency in French and/or German is required

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We are seeking an exceptional Pathologist with a proven industry track record of commercialization of in-vitro diagnostic assays and pathology education to join our Development Oncology & Pathology Organization.
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If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!