Companion Diagnostics Project Leader/Sr. Companion Diagnostics Project Leader - Oncology

Job description

  Job facts

The CDx PL/Sr. CDx PL 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/Sr. CDx PL will play a critical role in enabling personalized healthcare for Roche/Genentech therapeutic programs.

The CDx Project Leader will be responsible for the following:

·  Lead the companion diagnostic development strategy within Genentech Research and Early Development (gRED) and Product Development (PD) therapeutic programs and ensure alignment of companion diagnostic development milestones with clinical milestones and overall biomarker strategy
·  Manage multiple CDx development partnerships and execute on jointly defined deliverables, from assay development kick-off through diagnostic approval and launch
·  Provide critical technical expertise and collaborate closely with biomarker leaders, sample operations, clinical science and regulatory representatives on the successful implementation of companion diagnostic assays and diagnostic data collection in clinical trials
·  Develop and lead forward-looking diagnostic development strategies that enable broad access to high-quality diagnostic testing
·  In collaboration with diagnostic partners, co-lead the development of novel platforms, including multiplex technologies, to support investigational and approved pharmaceutical products

Who we are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Desired profile

Who You Are

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

Qualifications

·  Ph.D (preferred) in a Life Science or equivalent (M.S. with equivalent relevant experience is acceptable), plus at least 3-5 years of relevant work experience
·  Broad knowledge and understanding of established and novel clinical and diagnostic assay technologies (e.g., NGS, IHC, digital pathology, PCR, liquid biopsy). Hands-on experience with next-generation sequencing (NGS), including data analysis, is strongly preferred
·  Experience in the drug development process (clinical trials, efficacy endpoints, biomarker testing), including registrational studies, is strongly preferred
·  Strong understanding of the decision-making process in the biotech/pharma industry, and how diagnostic development strategy can influence drug development and commercialization
·  Understanding of the IVD development process, with CDx co-development, is preferred
·  Must be detail-oriented with strong project management and organizational skills in order to manage multiple teams across a variety of personalized healthcare projects
·  Ability to apply strategic thinking and agile mindset to adapt to the evolving personalized healthcare environment
·  Ability to work collaboratively across business areas and with diverse functional stakeholders, in order to successfully meet project deliverables
·  Strong written and verbal communication skills and ability to effectively communicate with cross-functional teams

·