Companion Diagnostics Project Leader/ Senior Companion Diagnostics Project Leader - Oncology
Company: Roche
Location: Daly City
Posted on: August 3, 2022
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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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