Digital Biomarker Clinical Integration Manager

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The Position

Digital health technology is transforming the way we develop personalized medicines for patients. Roche is dedicated to creating community- and regulator-accepted digital endpoints and digital outcomes that redefine the way we measure disease progression in clinical drug trials, and make them accessible to Biopharma companies and the research community.

We are looking for a Validation Manager to co-create and drive the validation strategy of computer systems and data flows supporting the collection, storage, processing and analysis of digital endpoints for multiple disease areas, to accelerate the development of novel digital biomarker data insights products.

We, the Digital Biomarker (dBM) Chapter in Roche Information Solutions, are an integrated team of scientists, technologists, data analysts and operationalization experts, that leverages mobile technologies like smartphones and wearables to collect objective and continuous sensor data from patients in clinical trials.

We co-create innovative digital remote monitoring concepts for sensitive and meaningful drug development endpoints, implement them in technology solutions, develop health related outcome measures with the data, seek community- and regulatory acceptance of corresponding endpoints and offer them to Biopharma companies and research institutes for use in clinical trials. Moreover, we are establishing the scientific foundations for disease monitoring and screening solutions in clinical practice.

• Execute our digital biomarker strategy to seamlessly integrate mobile sensor data workflows in the clinical development processes for customers with needs in areas of

  • Disease understanding
  • Company internal drug decision-making (phase I-II)
  • Regulatory treatment approval (phase III-IV)

• Establish a trusted partner relationship with clinical trial customer teams - from pre-sales conversations on RIS Digital Biomarker products through to study protocol development, study setup and until close-out of the clinical trial engagement

• Integrate, project manage and lead delivery of digital biomarker deployment in clinical trials with Roche Pharma and external customers

• Drive the remote patient monitoring parts of IRB/Ethics Committee submissions and addressing follow up questions.

• Develop translation, logistics, support and related processes, and select/manage vendors that provide these services at scale.

• Prepare and manage distribution of site supporting materials, including trainings.

• Provide operational support for digital biomarker solutions in studies, including by being the point of contact for support requests by physicians and study coordinators.

• Create and maintain accurate study level progress information through the efficient use of systems, tools and reports.

• Create and maintain centralized project/teamwork-spaces, including document creation and/or maintenance.

• Ensure effective end-to-end communication and information sharing via compilation of study-specific documents and resources.

• Establish and manage (matrix) teams of employees and additional contractors and consultants to deliver on your portfolio of clinical studies

• Represent Roche Digital Biomarkers at conferences and industry events

• University degree in Life Sciences or related field with a minimum of 3 years related experience in the pharmaceutical industry

• Good knowledge of Digital Biomarker or eCOA deployment and operations in clinical drug trials.

• Track record to guide diverse expert teams at the interface of clinical science, sensor technologies and informatics

• Relevant experience in the area of sensor data and digital biomarker development.

• Transparent communicator and able to apply…