Companion Diagnostics (CDx) Manager

Job description

  Job facts

Who We Are

At Roche, over 90,000 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.

The Position

The Companion Diagnostics Manager guides the strategy and implementation of fit-for-purpose companion diagnostics (CDx) in support of specific therapeutic programs of the Roche Pharma Research and Early Development (pRED) portfolio. The main focus of the activities is to plan the CDx development strategies for their intended use in alignment with the clinical development plan and to ensure the timely implementation by managing collaborations with diagnostic partners. You will co-lead joint project teams (JPT) which are the core interface between Roche Diagnostics and Roche pRED for any PHC collaboration focused on co-developing companion/complementary diagnostics.

The key responsibilities include:

·  Develop and lead the implementation of fit-for-purpose companion diagnostic assay strategies in support of pRED therapeutic programs and ensure alignment of companion diagnostic development milestones with clinical milestones and overall biomarker strategy
·  Manage CDx development partnerships and serve as the single point of contact to diagnostic partners by co-leading JPT's to execute on jointly defined deliverables, from assay development kick-off to transition to the late stage organization at LIP
·  Efficiently manage companion diagnostic development projects and provide timely updates to relevant functional teams regarding development status
·  Provide diagnostic 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

Who we are

At Roche, 94,000 people across 100 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.

Roche is an equal opportunity employer.

Desired profile

Who You Are

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

To be successful in this role, your profile includes:

·  University degree in life sciences, PhD
·  3-5 years of practical experience in industry based drug or diagnostic assay development
·  Broad knowledge and understanding of established and novel diagnostic assay technologies (e.g., IHC, digital pathology, immunoassays, PCR, NGS, liquid biopsy).
·  Understanding and experience in the drug development process (clinical trials, efficacy endpoints, biomarker testing)
·  Significant understanding and experience with development of diagnostic devices (IVDs) as well as understanding of the operational considerations in executing biomarker and companion diagnostic strategies in clinical development
·  Preferably an understanding of the regulatory requirements for approval of a companion diagnostic both from the device and clinical development perspective
·  Excellent planning, project management and organisational 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 partners informed regarding status of programs
·  Strong social and interpersonal skills - able to build and maintain relationships and cross functional networks with key internal and external partners

If you are proud of contributing and feel you have the dedication to teamwork and innovation that we are seeking, then Roche is the organization for you. Every role at Roche plays a part in making a difference to patients' lives. If you want work in a passionate team, make your mark & improve lives, apply now.

Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

If you have questions, please check our FAQs and videos on careers.roche.ch/faq.

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