Digital Endpoints Expert - Endpoints Capability Centre

323109BR
Jul 13, 2021
Ireland

Job Description

Novartis continues to accelerate its growth in the digital world. As part of our continued growth we're hiring a Digital Endpoints Expert within our Digital Endpoints Centre.

Our Digital Endpoints Expert will provide domain expertise across clinical, scientific and technology areas. You'll represent the Digital Endpoints Center across our organisation and be interlink between the digital technology solutions and trial management teams.

As our Digital Endpoints Expert, you'll impact positively on our Enterprise level projects including that generate major added value across Global Drug Delivery (GDD), Data & Digital and Customer Technology Solutions (CTS)., including Next Generation Engagement (NGE), PRecIsion MEdicine (PRIME) and Decentralized Clinical Trials (DCT).

If you're passionate about making a positive contribution to Digital Endpoint Programs and driving their implementation in partnership with a Global Program Team, then apply today!

Your Responsibilities include but are not limited to:

• Providing Digital Endpoint domain expertise across clinical, scientific and technology domains to support GPTs and CTTs.
• Coordinating, implementing and deploying Digital Endpoints within trials, acting as a link between digital technology solutions and trial management teams
• Representing the Digital Endpoints Center across the organization such as Global Drug Development (GDD), Data & Digital, and Customer & Technology Solutions (CTS).
• Working with Digital Endpoints Center, Global Program Teams/Global Clinical Teams/Clinical Trial Teams, External Development Operations and the IT team on adherence dashboard, digital health platforms, UK biobank, device issues/maintenance, market scans, data flow
• Ensuring current understandings of research and market trends on digital endpoints, leading validation studies (with Contract Research Organisations or internally as a study lead as required) to evaluate the accuracy and reliability of Digital Endpoint technologies for use in large scale clinical trials
• Working with Global Program Teams to understand clinical needs, selecting and implementing digital solutions in the clinical trials and translating these into DE-derived measures
• Partnering with Regulatory Affairs Innovation team & contributing to Briefing Books, regulatory strategy etc. to progress acceptance of Digital Endpoints with Health Authorities and to generate data supporting payer discussions
• Assuring quality of Digital Endpoints team output on key materials, such as Briefing books, analysis plans and internal documents as required
• Monitor & flag risks and issues to Digital Program Head, Development Unit Digital Endpoint Lead and Digital Endpoints Center Lead as need


Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What You'll Need:
• Degree or PhD in Life sciences/Pharmacy with solid understanding of clinical development, digital health technologies and trials execution
• Experience in clinical research with focus on digital health technologies or wearables in clinical trials, driving clinical trials using digital health technologies/digital endpoints
• Experience in development and validation of digital endpoints
• Understanding of requirements in different markets (US, EMEA) of digital technologies in clinical trials, including requirement from respective health authority, drug development, regulatory affairs, global medical affairs and post launch services knowledge
• Strong leadership and project management skills with ability to think strategically
• Good interpersonal and communication skills, Comfortable working in matrix organization as a part of multi-functional team
• Proficiency in English (oral & written)

Why consider Novartis?

769 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
CTS
NBS CONEXTS
Ireland
Dublin
Czech Republic
Spain
Research & Development
Full Time
Regular
No
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323109BR

Digital Endpoints Expert - Endpoints Capability Centre

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