Digital Biomarker Endpoint Scientist

Job description

·  Job facts

Who We Are

Roche's Pharma Research and Early Development Informatics (pREDi) team is the bridge between digital technology and science. We use digital technology to help drive medical innovation, truly Personalised Healthcare and the development of innovative treatments for patients.

The pREDi Digital Biomarker team leverage smartphones, wearables and other remote monitoring technologies to collect objective, sensitive and continuous sensor data and drive the development of novel endpoints. Together with a cross-functional Roche-team, we create innovative remote monitoring concepts, implement them, deploy them in clinical trials, develop outcomes with the data, and seek community- and regulatory acceptance. Our focus is on accelerating clinical development of novel therapies for patients, and creating the scientific foundations for disease monitoring and screening solutions in clinical practice.

The Position

You will be joining a team at Roche that is committed to redefining the measurement of MS disease progression in clinical development and clinical practice. You are a forward thinking innovator who will drive the development of digital clinical outcomes (COAs) and biomarkers, solve complex scientific and technical problems and interact with key stakeholders to incorporate the Digital Biomarker strategy. You will build and expand your professional network, acting as an ambassador for Digital Biomarkers at Roche both internally and externally, while sharing core Roche values.

As a Digital Biomarker Endpoint Scientist you will:

·  Work with cross-functional teams to define clinical development and validation strategies for sensor-based digital biomarkers and digital clinical outcomes (COAs)
·  Provide guidance on clinical study designs and the analyses required to get from raw sensor data to digital biomarkers and digital clinical outcomes, and ultimately clinical trial endpoints; draft input for protocols and informed consents
·  Design and execute advisory boards and qualitative studies, including physician and patient focus groups, to establish clinical meaningfulness and patient relevance of digital biomarkers and digital clinical outcomes and optimize the usability of remote patient monitoring solutions
·  For regulatory filing packages (e.g. FDA, EMA), provide digital biomarker and digital clinical outcome subject matter expertise and write required content and documentation
·  Represent the team in consortia and contribute to guidances related to digital endpoints (e.g. regulatory agencies, C-Path, IMI, Transcelerate)
·  Keep abreast of new developments in remote patient monitoring, digital biomarker and digital clinical outcome development, and MS drug development
·  Project manage the implementation and deployment of the remote patient monitoring solutions in clinical studies, train clinical sites and provide operational support
·  Manage internal and external stakeholders

Who we are

Bei Roche leisten 94,000 Menschen in 100 Ländern Pionierarbeit im Gesundheitswesen. Gemeinsam haben wir uns zu einem weltweit führenden, forschungsorientierten Healthcare-Konzern entwickelt. Unser Erfolg baut auf Innovation, Neugier und Vielfalt.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.

Desired profile

Who You Are

You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point. If you bring the following qualifications, we are looking forward to your application:

·  real passion for transforming healthcare using digital technology, especially for modernizing clinical endpoints in drug development and improving disease management and patient care
·  advanced degree in cognitive neuroscience, clinical neuroscience, outcomes research, psychometrics, or a related medical or natural science discipline
·  experience in clinical research and experimental design, ideally in a pharmaceutical or related industry setting
·  experience supporting novel endpoint development for clinical trials, including psychometric analyses
·  excellent analytical, communication and presentation skills
·  proven project management skills, including the ability to shape and manage project scope and effectively delegate
·  structured approach, with an ability to work in complex, fast changing environments
·  scientific, data driven mindset
·  self-starting, problem solving attitude
·  demonstrated interest and ability to learn new things
·  ability to build strong partnerships with stakeholders and influence without authority
·  strong business English

Should you have these additional nice-to-have skills, you might be the team member we are looking for:

·  experience with FDA/EMA regulatory interactions or regulatory consortias regarding clinical drug development and novel endpoints
·  previous clinical experience in neuroimmunological (e.g. Multiple Sclerosis), neurodevelopmental (e.g. Autism Spectrum Disorder), neurodegenerative (e.g. Parkinson's disease) and neuromuscular disorders (e.g. Spinal Muscular Atrophy)
·  experience with software development projects, and especially with functional requirement models like use case and user story development, and requirement gathering
·  previous experience with analyzing data and/or implementation of information workflows

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. Every role at Roche plays a part in making a difference to patients' lives. If you want work in a passionate team, make your mark & improve lives, apply now.

Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. 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 the pREDi Digital Biomarker team has made an important contribution to :

Multiple Sclerosis:

https://www.youtube.com/watch?v=Bqu64uBEE2c&feature=youtu.be

https://floodlightopen.com

https://www.btcalgary.ca/video/iframe/2226196965001/SkX1bBGY/5838106745001

https://www.roche.com/de/media/releases/med-cor-2018-10-02.htm

https://www.futuremedicine.com/doi/pdf/10.2217/nmt-2017-0054

https://www.roche.com/media/store/releases/med-cor-2017-10-27.htm

https://www.youtube.com/watch?v=6BPS5tl2RRc

https://www.youtube.com/watch?v=k8XulS3IxBc

Roche Digital Biomarker programme overview:

https://isctm.org/public_access/Autumn2018/Presentation/Gossens-Aut18.pdf

Parkinson's Disease:

https://onlinelibrary.wiley.com/doi/full/10.1002/mds.27376

Huntington's Disease:

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

https://medically.roche.com/en/search/pdfviewer.e2f056a3-8a05-4b97-9dc1-f816505c30ca.html

Schizophrenia:

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

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