Senior Digital Biomarker Technology and Science Lead

Information Technology      ·      Basel, Basel-City, Switzerland     ·    Full time

The Position

In Roche´s Pharmaceutical Research and Early Development organisation (pRED), we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.

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. We are looking for a scientific leader to co-create and drive the development and application of digital endpoints for multiple disease areas to accelerate the development of highly innovative medicines across the Roche drug pipeline.

Role Mission

We, the Digital Biomarker (dBM) Global Area in Roche’s Pharma Research and Early Development Data & Analytics (D&A) organization, 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, deploy them in clinical drug trials, develop health-related outcome measures with the data, and seek community- and regulatory acceptance of corresponding endpoints – together with a broad cross-functional expert Roche-team.

Moreover, we are establishing the scientific foundations for disease monitoring and screening solutions in clinical practice and exploring opportunities in the emerging space of Digital Therapeutics / Digiceuticals.

We’re seeking a future-thinking innovator who knows how to apply her/his expertise to help transform the healthcare industry.

Your impact

As Senior Digital Biomarker Technology and Science Lead you will “follow the science” to:

• Be accountable as the Digital Biomarker Disease Area lead for end-2-end scientific conceptualization to delivery of digital assessments in multiple therapeutic areas for drug decision-making (current focus: neuroscience and rare diseases).
• Partner with a broad stakeholder community: patients, caregivers, external and internal experts – to co-create digital endpoint strategies with project development and lifecycle teams (especially with Biomarker Experimental Medicine Leaders Cognitive Neuroscientists, Translational Medicine Leaders, Clinical scientists, Medical directors).
• Lead large interdisciplinary project teams that develop and implement the remote patient monitoring solutions enabling the above digital endpoint strategies (focus: concept development, technology implementation, clinical trial deployment, sensor data analysis and endpoint development).
• Actively drive the adoption and use of dBM by the project and lifecycle teams for internal and regulatory decision-making in the drug development pathway. 
• Establish yourself as a respected dBM 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.
• Engage external clinical, patient and regulatory experts to help shape remote patient monitoring solutions and sensor data endpoints throughout the lifecycle of Roche drug development projects.
• Co-create and drive our overall remote patient monitoring strategy

Your profile

We are looking forward to receiving your application highlighting:

• intrinsic passion for transforming healthcare using digital technology to modernize clinical endpoints in drug development
• Scientific university degree (PhD. level) in quantitative natural science or medical discipline with a focus on large-scale data analysis (e.g. biomedical engineering or science, cognitive science, neuroscience) and an excellent publication record 
• 8+ years of professional experience in the pharmaceutical or related industry, ideally directly impacting decision-making in clinical drug development
• track record of initiating and managing complex, interdisciplinary research and development projects and project teams (ideally software and technology implementation for clinical studies)
• extensive experience in the design of complex and long-term scientific experiments
• self-starting team player
• problem-solving attitude and structured approach to work in complex fast-changing environments
• excellent analytical, communication and presentation skills
• native English or equivalent, excellent writing skills

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
• 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
• Experience with developing digital biomarkers, digital clinical outcomes and digital endpoints
• FDA/EMA regulatory interactions or regulatory consortia regarding clinical drug development and novel drug development endpoints
• Previous clinical experience in Neurodevelopmental Disorders (especially Autism Spectrum Disorders), Parkinson’s Disease, Huntington’s Disease, Alzheimer’s Disease, Multiple Sclerosis, Neuromuscular atrophies/dystrophies. Other areas of growing importance include Inflammation, Immunology, Ophthalmology and Oncology.

Helpful links illustrating recent work in our Digital Biomarker Programme team:

• Roche Digital Biomarker programme overview:
  • Roche IR event: Digitalization along the value chain: https://www.roche.com/investors/events/digitalization-along-the-value-chain-2021-replay
  • EndpointsNews – panel discussion:https://vimeo.com/540337344/6ce691771c
  • https://isctm.org/public_access/Autumn2018/Presentation/Gossens-Aut18.pdf
• Parkinson’s Disease:
  • Nature scientific reports article on Ph2 study https://www.nature.com/articles/s41598-022-15874-4
  • Movement disorders article on Ph1 study:https://onlinelibrary.wiley.com/doi/full/10.1002/mds.27376
  • Nature Digital Medicine article on Digital Endpoint development:https://www.nature.com/articles/s41746-020-0305-8
• Multiple Sclerosis:
  • Overview article:https://www.nature.com/articles/d42473-019-00412-0
  • Open access clinical trial webportal:https://floodlightopen.com
  • Summary of Proof-of-Concept Results: https://journals.sagepub.com/doi/full/10.1177/13524585211028561
  • Patient satisfaction and adherence:https://www.jmir.org/2019/8/e14863/
  • 2-minute walk test:https://ieeexplore.ieee.org/document/9103259
  • U-turn speed: https://www.sciencedirect.com/science/article/pii/S0966636220306500?via%3Dihub
  • Draw-a-shape:https://iopscience.iop.org/article/10.1088/1361-6579/ab8771
  • Patient perspective:https://m.youtube.com/watch?v=Co9yZti0aPM&t=170s
  • Physician perspective:https://www.youtube.com/watch?v=k8XulS3IxBc
• Huntington’s Disease:
  • Article: https://www.jmir.org/2022/6/e32997/
  • Poster:https://medically.roche.com/en/search/pdfviewer.70e37898-f136-47f4-9861-13fe82938a2a.html
• Schizophrenia:
  • Article: https://www.frontiersin.org/articles/10.3389/fpsyt.2020.574375/full

Our commitment

Roche commits to recognizing talent and aptitude. We prioritize encouraging and supporting our employees on their personal journeys by providing a safe, creative space to help them reflect, make decisions and grow in their career.We are confident that we find the most innovative solutions by gaining different perspectives, asking and answering hard questions, and challenging the status quo. Roche embraces diversity and equal opportunity in a serious yet enthusiastic way; we are devoted to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

Who we are

At Roche, more than 100,000 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.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.

Please click here to apply.