CDx Project Leader

Organization
Genentech
Job Location
South San Francisco, CA 94080
Job Description

Join a Team that Lives to Improve Lives

People come to Genentech from across disciplines and across the world to solve our most challenging medical conditions. You’ll find inspiration in our passion for biotechnology, our purpose to positively impact the lives of millions of patients and our dedication to our people. Joining Genentech means being part of a tradition of inquiry that will change the world. It means embracing our failures as much as our successes. It requires a willingness to look beyond the edge of what's possible. And a focus on doing the day-to-day work that makes great science happen.

The following opportunity exists in our South San Francisco, CAheadquarters: 

CDx Project Leader

Description

The CDx Project Leader will guide the strategy and implementation of companion diagnostics in support of projects within Genentech’s extensive Early and Late Development portfolios. The CDx PL will also take responsibility for execution of exploratory analyses through close collaboration critical and will play a critical role in enabling the implementation of personalized healthcare for Roche/GNE therapeutic programs.

The CDx Project Leader will be responsible for the following:

  • Provide guidance on the companion diagnostic strategy to the biomarker teams within Genentech Research and Early Development (gRED) and Product Development (PD) therapeutic programs and ensure alignment of companion diagnostic development milestones with clinical milestones
  • Manage multiple CDx development partnerships and serve as the single point of contact to diagnostic partner to execute on jointly defined deliverables.
  • Efficiently manage multiple companion diagnostic development projects with diagnostic partners and provide timely updates to relevant functional teams regarding development status
  • Provide technical expertise and work closely with biomarker leaders, sample operations, clinical operations and regulatory representatives on the successful implementation of companion diagnostic assays in clinical trials
  • Collaborate with clinical operations and sample management to ensure optimal biomarker testing and diagnostic data collection in clinical trials.
  • Develop and lead IVD strategies that are aligned with disease areas, including development of multiplex platforms to support investigational and approved products in collaboration with diagnostic partners.

Who You Are

The ideal candidate for the CDx Project Leader will meet the following qualifications:

Qualifications

  • Ph.D in a Life Science or equivalent / MBA with MS in a Life Science or equivalent
  • 3-5 years’ experience in diagnostics or biomarker development with emphasis on Non-Oncology, oncology or immunology; understanding of drug development process is preferred.
  • Strong understanding of technology and IVD development is required.
  • Previous experience with diagnostic technologies and platforms preferred, including strong understanding of nucleic acid-based technologies including next generation sequencing, IHC, FISH, and immunoassay technology.
  • Must be detail-oriented with strong project management and organizational skills in order to manage multiple projects and meet assigned deliverables.
  • Ability to work well on teams and keep relevant stakeholders informed regarding status of programs.
  • Strong written and verbal communication skills and ability to effectively communicate with cross-functional teams
How to Apply

 A Job with Benefits Beyond the Benefits

No matter who you are or what role you play, you’ll help change the face of medicine and make a real difference in the lives of people facing the most challenging medical conditions. Plus, you’ll thrive in our one-of-a-kind culture, where diversity is celebrated, employees are valued for their contributions and we all serve as advocates for change who continually find ways to do things better.

The next step is yours. To apply today, click on the "Apply" button below.

Genentech, a member of the Roche Group, has multiple medicines on the market for cancer and other serious illnesses.

Genentech is an Equal Opportunity Employer: Minorities/Women/Disability/Veteran         

Apply link:

http://www.gene.com/careers/find-a-job/apply/00446101?src=JB-11480

About Our Organization

Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. We are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.

Gladys Kong writes at Fortune that her STEM background has helped her as a CEO.

Social scientists report that the image of the 'lone scientist' might be deterring US students from STEM careers.

Postdocs supported by external funding are less likely to have access to paid parental leave, Nature News reports.

The US National Institutes of Health's new plan will bolster support for early- and mid-career investigators.