Sr. Manager, Companion Diagnostics Development
Genentech - Switzerland, FL

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We are
seeking

one or more

highly motivated
individuals to join the Oncology Biomarker Development Dept. to lead companion
diagnostic (CDx) development programs in support of the Roche / Genentech early
and late stage Oncology clinical development pipeline. The incumbent will
provide leadership for a portfolio of molecules within a Franchise and
represent these programs to senior management and decision-making bodies
internally.

The CDx development strategies will be closely aligned with
clinical development program timeline and strategy to enable robust clinical
validation of the CDx, including establishment of thresholds and statistical
analysis of the relationship with efficacy or safety using robust assays
developed with diagnostic partners. The incumbent will also develop cross-
functional relationships with internal scientific, operational and regulatory
groups and diagnostic partners, and represent GNE / Roche CDx efforts to
external professional organizations and regulatory bodies. The successful
candidate will also be expected to contribute to Medical Affairs strategies to
enable biomarker hypothesis testing.

Responsibilities

Work closely
with the biomarker, regulatory, statistics and clinical leadership to ensure
development and effective operational execution of the CDx portfolio of
multiple investigational agents in Franchises or Disease Area

Management of
direct and matrixed reports whose responsibilities will include programs in
both early and late stage clinical development. A substantial focus will be in
early development where design of CDx strategies that enable device development
in preparation for hypothesis testing will be important. Therefore requires
strong understanding and experience with development of diagnostic devices in
order to develop fit for purpose CDx strategies.

Develop and
lead strategic initiatives to identify novel CDx technologies and develop
relationships to enable effective evaluation of technologies as CDx assays.

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.

Enable the
coordination and execution of exploratory biomarker hypothesis testing in the
clinic.

Develop
relationships with external key investigators, scientists and professional
organisations in the diagnostic technology field to inform internal CDx
strategies including next generation technology implementation and validation.

Represent CDx
strategy to health agencies as part of the regulatory strategies for the agents
within the entire portfolio.

Qualifications

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies.

Where a job title is not considered the final definition of who you are, but the starting point.

PhD or MD/PhD degree with research
experience in Oncology, preferably in a translational context.

Post-doctoral experience in technology
development or translational research is preferable

Highly experienced in biomarker /
companion diagnostic development with a proven track record of excellence
during 5+ years of experience in an industrial Oncology development context.

Strong understanding of technology and IVD
development is required.

Demonstrated experience in companion
diagnostic development and IVD development preferred and understanding of the
regulatory requirement for approval of a companion diagnostic both from the
device and clinical development perspective

Strong understanding of the operational considerations
in executing biomarker and companion diagnostic strategies in clinical
development is required.

Strong track record of publications in
clinical research as well as contribution/authorship of documents for
regulatory submission.

Outstanding presentation and communication
skills; ability to

Lead, influence, and motivate others

Distill complex issues and clearly
articulate / present solutions

Ability to work across different cultures

Ability to travel up to 20%, including
domestic and international travel

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

Who we are

At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 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.

Genentech - 18 months ago - save job - block
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