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Companion Diagnostics Project Leader/ Senior Companion Diagnostics Project Leader - Oncology

Company: Roche
Location: Daly City
Posted on: August 3, 2022

Job Description:

The PositionThe CDx PL/Senior CDx PL will guide the strategy and implementation of companion and clinical diagnostics in support of projects within Roche/Genentech's extensive Early and Late Stage Development portfolios. The CDx PL/Senior 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:Develop and lead the companion and clinical diagnostic (CDx) strategies within Genentech Research and Early Development (gRED) and Product Development (PD) therapeutic programs and ensure alignment of companion and clinical diagnostic development milestones with clinical milestones and the overall biomarker strategy.Manage multiple CDx development partnerships and execute on jointly defined deliverables, from early assay development planning and assay development kick-off through diagnostic approval and launch.Provide critical technical expertise and collaborate closely with biomarker leaders, sample operations, clinical science, clinical operations, and regulatory representatives on the successful implementation of CDx 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 at launch.In collaboration with diagnostic partners, co-lead the development of diagnostic platforms, including multiplex and emerging technologies, to support investigational and approved pharmaceutical products.The ideal candidate for the CDx Project Leader/Senior CDx Project Leader will meet the following qualifications:Ph.D. (preferred) in a Life Science or equivalent (M.S. or B.A. with equivalent relevant experience is acceptable), plus at least 3-5 years of relevant work experienceBroad knowledge and understanding of novel and established clinical and diagnostic assay technologies (e.g., IHC, ISH, Digital Pathology, NGS, PCR, liquid biopsy, MRD). Hands-on experience with diagnostic assay development and data analysis, is strongly preferredExperience in the drug development process (clinical trials, efficacy endpoints, biomarker testing), including registrational studies, is strongly preferredStrong understanding of the decision-making process in the biotech/pharma industry, and how diagnostic development strategy can influence drug development and commercializationFamiliarity with the CDx landscape in Cancer Immunotherapy (CIT) is preferredUnderstanding of the IVD development and regulatory considerations; CDx co-development is preferredMust be detail-oriented with strong project management and organizational skills in order to manage multiple teams across a variety of personalized healthcare projectsWho we areA 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.Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company's health and safety obligations and/or applicable law or guidelines.Diversity and Inclusion (D) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.Genentech is an equal opportunity employer,and we embrace the increasingly diverse world around us.Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage.

Keywords: Roche, Daly City , Companion Diagnostics Project Leader/ Senior Companion Diagnostics Project Leader - Oncology, Other , Daly City, California

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