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
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:
- 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