Senior Director, Global IVD Applications Support

Genomic Health, Inc.   •  

Redwood City, CA

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 57 days ago

Job ID 1098 Category Engineering

Job Location Redwood City, California

Posted Date 08/27/2018

Overview:

Genomic Health, the world's leading provider of genomic-based cancer diagnostic tests, is seeking a Senior Director of Global IVD Applications Support to join the Operations team. Reporting to the SVP of Operations, the successful candidate will be directly responsible for building and managing a new Applications Support team based in our Redwood City headquarters location. This will include hiring and direct management of employees in the US and dotted line management of employees in Europe. This team will create the training materials, processes and systems that will ensure efficient introduction and successful ongoing use of Genomic Health IVD products by laboratories worldwide. He or she will lead the ongoing improvement of these training and support mechanisms as these IVD products are launched in a growing number of countries, ensuring their efficiency and effectiveness both internally and for customer laboratories using these IVD products to provide Oncotype results to patients. The Senior Director, Global IVD Applications Support will collaborate closely with Sales, Customer Service, Product Lifecycle Management, R&D, Quality, Operations and other departments to achieve these objectives.

This is a rare opportunity to build a new customer-facing team and a new global capability at Genomic Health, directly associated with one of our most exciting growth areas. It requires extensive experience developing and delivering customer training and support for IVD products and building and leading a team with global responsibilities in this area.

RESPONSIBILITIES / DUTIES:

· Hire and directly manage Genomic Health's Global Applications Support Team,
building the depth and breadth required for customer support on IVD systems
including assay kits, software, and instrumentation
· Continually mentor and develop this team to further enhance its capabilities,
leading by example
· Lead the development of training materials, processes, and systems for
worldwide customer training, installation and qualification of instruments and
software at customer sites, collaborating closely with Commercial, Product
Lifecycle Management, R&D, Engineering, Quality, and other functions.
· Develop, oversee, and continuously improve a training and training
certification program for customer labs worldwide who are introducing
Oncotype testing within their facilities, and develop the systems and processes
needed to ensure the effectiveness of this training
· Lead the development of written procedures and training materials for
installation and qualification of IVD instrumentation and software by Field
Application Specialists
· Develop, oversee, and continuously improve a training program for Field
Application Specialists worldwide on installation and qualification of
instruments and software for Genomic Health IVD products
· Provide ongoing guidance to Field Application Specialists worldwide on the
above customer training and support documentation, processes, and systems
· Lead the development and implementation of documented processes for
escalation of complex customer problems and questions from Field
Application Support staff to Global Applications Support, resolution or further
escalation by Global Applications Support, and the generation of traceable
records of all internal and customer-facing activity following a customer issue.
· Oversee the Global Applications Support team's ongoing resolution or
escalation of customer issues to ensure timeliness, effectiveness, and a superb
customer experience
· Collaborate with Quality, Commercial, Product Lifecycle Management, and
other groups to develop and continuously refine systems and processes for
collecting, analyzing, and acting upon customer feedback from site visits,
phone calls, emails, and other relevant sources, maximizing Genomic Health's
ability to learn about and continuously improve the experience of customers
using these IVD products
· Develop strategies for efficient, effective training of multiple customer
laboratories upon commercialization of IVD products in new countries or
regions
· Provide input to new product development teams, Product Lifecycle
Management, R&D, Engineering, and other groups on Design for Serviceability
/ Maintainability and potential product improvements



QUALIFICATIONS:
Required
· M.S. or Ph.D. in relevant scientific or engineering field
· At least eight years of hands-on experience as an Application Specialist for
molecular diagnostics products (assays and software), preferably in oncology
· At least five years managing a team of international Application Specialists,
with either direct or dotted-line management responsibility for employees
outside the US (preferably Europe and/or Asia)
· A successful track record in leading the development and delivery of training
for customers on use of IVD systems for patient sample testing, within and
outside the US
· Demonstrated ability to lead a successful second-level Application Support
function, efficiently resolving complex customer issues escalated by Field
Applications Specialists
· Demonstrated ability to collect, organize, and use customer feedback to drive
ongoing improvement in products and services
· Experience working with regulated clinical and/or pathology laboratories
internationally and in the US
· Entrepreneurial mindset, with experience working for both large and small
organizations and a strong desire to work in a fast-paced, highly
interdisciplinary environment with rapidly changing priorities
· A track record of exceptional communication, collaboration, and teaching skills,
demonstrated at all levels of the company and with customers
· Effective complex problem-solving skills
· Detail-oriented with strong organizational skills

Desired
· Proficiency in either French, German or Italian
· Familiarity with software in IVD products
· Strong working knowledge of ISO13485 and/or FDA QSR's