Director of CLIA LifeLab

Organization
Thermo Fisher Scientific
Job Location
Sacramento, CA
Job Description

The Clinical Lab team is a group of passionate individuals dedicated to changing the way medicine is practiced. At our disposal are the considerable resources of an innovative global biotech company. We work with leading pharmaceutical companies to develop companion diagnostics assays, which will allow the most beneficial use of novel and innovative drugs. Access to the latest technology, like Ion Torrent sequencers, will enable us to provide new treatment options for oncologists to help their patients and screen newborns for inherited diseases. The team is looking for an individual who has the drive and passion to join our quest in the evolution of personalized medicine. You will have the opportunity to directly impact patients through the design and development of leading edge IVD systems. Talented individuals who share our beliefs should apply for this position to help develop IVD systems to benefit patients in ways not possible before.

The team, which will be led by the successful candidate, is focused on the development of RUO and IVD NGS assays with a focus on oncology for the US, Europe, Japan, and China. These assays will either be developed as companion diagnostic products for pharmaceutical companies or as IVD catalog products for Thermo Fisher Scientific.

Responsibilities and Functions:

The Director of CLIA LifeLab will report into the VP of R&D and lead a team of approximately 10 – 15. He/she will be responsible for hiring and structuring the organization to successfully meet the development goals to become one of the strongest IVD development teams in the industry.

  • Be the scientific point of contact for our pharmaceutical partners.
  • Work closely with a CLIA lab, which will provide design input for new products. Interact with all other functions within the company to launch IVD assays in the target markets. This includes the regulatory, QA, QC, manufacturing, marketing and business development teams.
  • Within the R&D organization close collaboration with the Diagnostics Partnering Group (DxP) is required.
  • Manage a budget.
  • Ability to manage the scientific relations with external pharmaceutical partner companies.
  • Solid scientific background.
  • Generate alternative solutions and manage risk by identifying criteria for trade-off decisions and helping to facilitate difficult conversations.
  • Demonstrated understanding of company’s external customer needs and how they affect business unit products and services.
  • Interact positively with all cross functional development team members.
  • Build and maintain relationships with customers, key opinion leaders and pharmaceutical partners.
  • Self-motivated and a driving force of successful timely execution.
  • Work within a diverse team and contribute to a positive work environment.
  • Excellent ability in ensuring the team documents experiments meeting all requirements to establish an acceptable Design History File. The quality of documentation must be good enough to support patent claims and withstand the scrutiny of all audits.
  • Influence stakeholders in other functions over whom the Director of LIfeLab has no direct authority.
  • Highly-motivated driver able to complete tasks by leveraging relationships and established goals.
  • Willingness to be flexible and adaptable in a complex, matrixed environment.
  • Able to adapt to changing needs and parameters caused by time, budget, or other constraints.
  • Acts as a mentor/role model for team members.
  • Communicate effectively internally and also with decision makers, external scientists and customers.
  • Proven ability to execute through influence within a matrixed organization.
  • Maintain all licenses necessary to operate the LifeLab’s CLIA lab in the state of CA, receiving specimens for clinical processing and reporting from the 50 United States and clinical specimens for clinical trials from international geographies such a Japan.
  • Maintain all local licenses, certificates for the city of W. Sacramento, CA.
  • Responsible for all annual budget planning and long term strategic planning input for LifeLab.
  • Lead the hiring process for all LifeLab employees
  • Ensure all LifeLab employees undergo full career development planning and execution on an annual basis.

 

Requirements

 

  • CA CLS licensed with min of 2 +yrs. supervision in a high complexity NGS assay environment.
  • A Life Sciences Ph.D. or qualified experience
  • Experience performing (versus developing) NGS tests (high complexity molecular tests) on patient specimens in a CLIA lab.
  • Led a team which successfully launched an IVD or blood screening assay (e.g. European CE-IVD, Japan IVD or FDA) Development of a product which had a successful PMA launch is strongly preferred.
  • Must have feasibility work on actual or prototype assays and most importantly the responsibility to sign off on all NGS results for reporting to hospital, physician and patient.  
  • Oversees CLIA Lab operations and its personnel.
  • 10+ years’ work experience in molecular IVD diagnostics. Especially experience with development of real-time PCR assays is needed.
  • Experience in managing the relationship with a major pharmaceutical company is needed.
  • Experience in working with a regulatory team to support clinical trials resulting in successful regulatory submissions is needed. Generating or evaluating requirements/specification for IVD assays. Assay validation knowledge.
  • Understanding customer needs and pains, through direct interaction with customers.
  • Experience with cancer diagnostics is a big plus.
  • Experience hiring and managing employees

At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
 
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

About Our Organization

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our five premier brands, Invitrogen, Applied Biosystems, Thermo Scientific, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com