Offers “Roche”

Expires soon Roche

Companion Diagnostics Project Leader - Oncology

  • South San Francisco (San Mateo County)
  • Project / Product management

Job description

  Job facts

Considering local candidates only.

The 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 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 strategy on 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 and overall biomarker strategy.
·  Manage multiple CDx development partnerships and serve as the single point of contact to diagnostic partner to execute on jointly defined deliverables, from assay development kick-off to diagnostic launch
·  Efficiently manage multiple companion diagnostic development projects and provide timely updates to relevant functional teams regarding development status
·  Provide technical expertise and work closely with biomarker leaders, sample operations, clinical science 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 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.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at .
EEO is the Law

PAY TRANSPARENCY NONDISCRIMINATION PROVISION
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Desired profile

Who you are

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.

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

Qualifications

·  Ph.D (preferred) in a Life Science or equivalent. M.S. degree will be considered for exceptional candidates.
·  3-5 years of experience in companion diagnostic development with emphasis in oncology
·  Deep knowledge and understanding of relevant assay technologies (e.g., IHC, PCR, and NGS).
·  Understanding and experience in the drug development process (clinical trials, efficacy endpoints, biomarker testing)
·  Strong understanding of IVD technologies and IVD development process is required
·  Must be detail-oriented with strong project management and organizational skills in order to manage multiple projects and meet assigned deliverables
·  Strategic agility and ability to adapt to the evolving personalized healthcare environment
·  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
*LI-gRED-MD2

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