Job Detail

Digital Biomarker Technology Science Lead

Inseriert am: 06.03.2021

Roche's Pharma Research and Early Development Informatics team is the bridge between digital technology and science. We help drive medical innovation and are integral to the realisation of truly Personalised Healthcare and the development of innovative treatments for our patients.


The Digital Biomarker team leverages remote monitoring technologies like smartphones and wearables to collect objective and continuous sensor data from patients in clinical trials and drive the development of novel sensitive and meaningful drug development endpoints. We co-create innovative remote monitoring concepts, implement them, 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 Roche-team. Our primary focus is on more successful clinical development of novel therapies for patients. Moreover, we are building the scientific foundations for disease monitoring and screening solutions in clinical practice and explore opportunities in the emerging space of Digital Therapeutics / Digiceuticals.


Roche is dedicated to creating community- and regulator-accepted endpoints and outcomes that will redefine the measurement of disease progression. We’re seeking future-thinking innovators who know how to apply their expertise to help transform the healthcare industry.


The Position
 


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



  • Become accountable for end-2-end delivery of your digital biomarker portfolio in multiple disease areas (current main focus: Neuroscience and Rare Diseases).


  • Co-create digital biomarker and digital clinical outcome strategies with clinical development teams (especially with Biomarker Experimental Medicine Leads - e.g. Cognitive Neuroscientists, Neuroimaging Experts, and/or Electrophysiologists, and Translational Medicine Leads - e.g. Psychiatrists and/or Neurologists).


  • Lead large, interdisciplinary project teams that develop and implement the remote patient monitoring (RPM) solutions enabling the digital endpoint strategies, with a particular focus on concept development, technology implementation, clinical trial deployment, sensor data analysis, and endpoint development.


  • Oversee the implementation of RPM analyses and the communication of results, including at conferences and in peer-reviewed publications for audiences in thetherapeutic area of interest, sensor science, machine learning and digital medicine.


  • Engage external clinical, patient and regulatory experts to shape RPM solutions and sensor data endpoints throughout the lifecycle of Roche drug development projects


  • Contribute to shape and drive our overall remote patient monitoring strategy.


  • Drive the use of RPM data for Roche internal and global regulatory drug development decision-making; shape RPM analysis plans to support this decision-making


  • Establish yourself as a respected expert and advocate in the research and development community at Roche and externally


  • Explore the emerging space of Digital Therapeutics/Digiceuticals



Who You Are
 



  • If you bring the following qualifications, we are looking forward to receiving your application:



    • intrinsic passion for transforming healthcare using digital technology, and especially for using these novel technologies to modernize clinical endpoints in drug development and improve disease management and patient care


    • very good university degree (PhD. level) in e.g. biomedical engineering or science, cognitive science, neuroscience or a related medical or quantitative natural science discipline with a focus on large-scale data analysis and an excellent publication record 


    • 6+ years professional experience in the pharmaceutical or related industry, with direct senior involvement in clinical development


    • track record of initiating and managing complex, interdisciplinary research and development projects and project teams, especially in the fields of software and technology implementation in support of clinical studies


    • extensive experience in the design of scientific experiments


    • excellent analytical, communication and presentation skills


    • self-starting teammate


    • problem solving attitude and structured approach to work in complex fast changing environments


    • 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 consortias regarding clinical drug development and novel drug development endpoints


  • previous clinical experience in Multiple Sclerosis, Parkinson’s Disease, Huntington’s Disease, Neuromuscular atrophies/dystrophies, Autism Spectrum Disorders, Alzheimer’s Disease. Other areas of interest include Inflammation, Immunology, Ophthalmology and Oncology.



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.


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.


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


Roche Digital Biomarker programme overview:



  • isctm.org/public_access/Autumn2018/Presentation/Gossens-Aut18.pdf



Multiple Sclerosis:



  • Overview article:www.nature.com/articles/d42473-019-00412-0


  • Open access clinical trial:floodlightopen.com


  • Patient satisfaction and adherence:www.jmir.org/2019/8/e14863/


  • 2-minute walk test:ieeexplore.ieee.org/document/9103259


  • U-turn speed: www.sciencedirect.com/science/article/pii/S0966636220306500?via%3Dihub


  • Draw-a-shape:iopscience.iop.org/article/10.1088/1361-6579/ab8771


  • Patient perspective:www.youtube.com/watch?v=6BPS5tl2RRc


  • Physician perspective:  www.youtube.com/watch?v=k8XulS3IxBc



Parkinson’s Disease:



  • Article on Ph1 study:onlinelibrary.wiley.com/doi/full/10.1002/mds.27376


  • Nature Comment on Digital Endpoint development:www.nature.com/articles/s41746-020-0305-8



Huntington’s Disease:



  • Blog:curehd.blogspot.com/2018/03/roche-gears-up-for-pivotal-phase-3.html


  • Poster:medically.roche.com/en/search/pdfviewer.70e37898-f136-47f4-9861-13fe82938a2a.html



Schizophrenia:



  • Poster:isctm.org/public_access/Autumn2018/PDFs/Umbricht-Poster.pdf$


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