Digital Biomarker Solutions Manager
vor 2 Monaten
About the Role
We are seeking a highly skilled Digital Biomarker Scientific Solutions Manager to join our team at Roche Information Solutions. As a key member of our integrated team of scientists, technologists, data analysts, and operationalization experts, you will play a crucial role in leveraging mobile technologies to collect objective and continuous sensor data from patients in clinical trials.
Key Responsibilities
- Partner with a broad stakeholder community of patients, caregivers, physicians, 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, regulatory treatment approval, clinical trial participant selection, and clinical care.
- Identify and develop scientific concepts to address unmet measurement needs.
- Oversee end-to-end scientific product development.
- Lead large interdisciplinary project teams that develop and implement 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.
Requirements
- 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).
Nice-to-Have Skills
- 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.
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