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.