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Digital Biomarker Scientific Solutions Manager
vor 7 Monaten
The Position
Job Mission
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.
You will be responsible to …
Partner with a broad stakeholder community of patients, care givers, physician and other experts to create digital health solutions
Act as scientific product owner for a set of digital biomarker solutions for Roche and external customers with needs in areas of Disease understanding / Drug portfolio decision-making (phase I-II) / Regulatory treatment approval (phase III-IV) / Clinical trial participant selection / Clinical care
Identify and develop scientific concepts to address the unmet measurement needs
Oversee end2end scientific product development
Lead large interdisciplinary project teams that develop and implement the scientific digital biomarker solutions
Drive the drug development tool regulatory strategy for digital endpoint endorsement and qualification
Drive scientific community acceptance of digital measures and maintain a strong network of collaborators spanning industry and academia
Develop scientific core messages for product marketing
Support interactions with customers during the pre- and post-sales phases
Represent RIS scientifically in pre-sales conversations on RIS Digital Biomarker products
Co-author high-profile scientific publications and posters
Represent Roche at relevant high-profile conferences
Establish yourself as a respected scientific digital biomarker expert and advocate in the research and development community at Roche and externally through cross-industry task forces, communicating results at conferences and in peer-reviewed publications.
Your profile:
University degree or equivalent) in Life Sciences or related field with a minimum of 10 years related experience in the pharmaceutical and digital health industry
Track record of writing compelling publications in high impact, peer reviewed journals
Proven experience with senior stakeholder management and external collaborations
Deep scientific product management experience in a large Pharma or Medtech company
Deep experience in the area of sensor data and digital biomarker development
Provable experience leading in matrix setup, recognized for embracing new ways of leading and working, with strengths in coaching and fostering a collaborative environment
Transparent communicator and able to apply effective empowering leadership
Previous clinical experience in Neuroscience (especially Parkinson’s Disease, Huntington’s Disease, Multiple Sclerosis)
Should you have these additional nice-to-have skills, you are the ideal team member we are searching for:
Hands-on work with sensor or other high frequency/complex time series data, including feature engineering
Experience with developing digital biomarkers, digital clinical outcomes and digital endpoints
FDA/EMA regulatory interactions or regulatory consortias regarding clinical drug development and novel drug development endpoints
Deep experience with software project ownership, and especially with functional requirement models like use case and user story development, and requirement gathering
Experience with engineering hardware for remote patient monitoring and sensor data collection