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The Translational Medicine department leads biomarker discovery and development efforts for programs in Early Stage Research through Phase III clinical trials using pharmacodynamic biomarkers to evaluate target engagement and mechanism of action of candidate therapies as well as prognostic and predictive biomarkers to guide patient selection and personalized healthcare strategies. Additionally, Translational Medicine conducts foundational clinical translational research to study the molecular and cellular pathways driving disease to generate novel target and biomarker approaches. The Biomarker Operations group within Translational Medicine  is responsible for developing and executing operational plans to deliver these biomarker strategies.

The Opportunity:

As a valuable member in the Biomarker Operations group you will be:

Partnering closely with Translational Medicine scientists and leaders during biomarker and companion diagnostic strategy development and execution to effectively create operational plans for both clinical trial and translational research projects.

Overseeing all operational activities required to manage the lifecycle of biomarker samples (collection, processing, shipment, storage, analysis, data delivery, and final sample disposition).

Ensuring collection, delivery and analysis of biospecimens under the highest standards of quality, ethics, informed consent, and adherence to ICH/GCP (including providing responses to biomarker sample related questions or issues from Health Authorities or Ethics Committees)

Serving as the biomarker operations representative on cross-functional teams, internal review committees, and external vendor/ diagnostic partner joint teams to provide operational expertise and oversight to drive on-time completion of deliverables (e.g. feasibility assessment, clinical documents, site/ vendor training, vendor/ assay identification/ selection/ management etc.).

Using operational, clinical, and project management expertise to track key activities (budget, sample status, data delivery, vendor KPIs) and developing metrics/ reports for clinical and biomarker teams to enable informed decision making.

Forming and maintaining effective working relationships with internal and external stakeholders (e.g. members of Biomarker and Clinical sub-teams incl. Clinical Science, Clinical Operations, Data Science, Research, Global Procurement, CROs, central labs, diagnostic partners, biomarker vendor team members).

Who You Are:

Life sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required. Further qualification, e.g. PhD and/or project management certification is desirable.

Minimum 3-5 years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment and with >4 years direct biomarker operations experience.

Extensive clinical development and biomarker operations experience with evidence of working on cross-functional teams running clinical studies/ complex collaborations.

Preferred candidates will have prior experience outsourcing assays and managing vendors.

Excellent oral/written communication and influencing skills and demonstrated success working cross-functionally is required.

A demonstrated record of using project management methods (highly detail oriented, ability to organize and communicate complex concepts/ deliverables and manage timelines) in a rapidly changing, fast-paced, global environment. 

Proven critical thinking skills and ability to navigate uncertainty by using independent problem solving skills.

Relocation benefits are available for this job posting.

The expected salary range for this position based on the primary location of California is $124,200 - $230,600 of hiring range.  Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.  A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Benefits

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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.