Development Unit Digital Endpoints Lead

326388BR
Sep 17, 2021
Ireland

Job Description

Novartis continues to accelerate its growth in the digital world. As part of our continued growth we're hiring a Development Unit Digital Endpoints Lead (DUDEL) .

Our DUDEL is a key member of the Digital Endpoints centre. You'll provide in-depth knowledge of established Digital Endpoints that are relevant for Novartis clinical and medical programmes, and brings external domain knowledge related to new and established digital biomarkers.

In this role, you'll provides advice and support to colleagues in CONEXTS (solutions partner that adds value for the larger enterprise), Global Drug Development, General Medical Affairs and other parts of Novartis on the use of novel Digital Endpoints as relevant for the indication and stage of development. Our Endpoints lead will understand the evolving regulatory environment related to digital therapeutics, and the impact this may have on digital endpoint use at Novartis.

You'll build and mature the digital endpoint service, enabling training of existing colleagues in this new area, and expansion of the service in collaboration with business partners.

Our DUDEL will contribute to enterprise level high impact projects that generate major added value, including Next Generation Engagement (NGE), PRecIsion MEdicine (PRIME) and Decentralized Clinical Trials (DCT)

Your responsibilities include but are not limited to;

• Providing expert support to project/product teams on the use of digital technologies in Novartis-sponsored clinical trials, taking in to account therapeutic area, phase of development, regulatory jurisdiction and clinical feasibility
• Collaborating with medical colleagues (e.g. Medical Experts) to build internal knowledge and skills in the area of digital endpoints and their use in clinical trials
• Engaging closely with key partners, including IT, procurement and Novartis Digital Health Solutions to enable qualification and onboarding of third party tech providers as relevant
• Working with internal and external partners to enable the use of selected digital endpoints through the use of devices, sensors and other relevant solutions
• Developing training for Novartis associates on the use of digital health technologies in clinical trials, linking with the Novartis strategy for decentralized clinical trials
• Managing and oversee the delivery of digital clinical trial projects, as agreed with partners
• Driving process and service excellence in digital clinical trials, providing expert support to CONEXTS teams
• Growing the CONEXTS capacity to deliver the Digital Endpoints service, in line with agreed service targets and priorities
• Managing the P&L for the Digital Endpoints service

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 in Life Sciences/Pharmacy with a solid grasp of clinical development and trial execution.
• Extensive experience in clinical research and/or bioinformatics, with a focus on digital health and clinical trials. Experience of development and validation of digital endpoints, including interactions with regulators/payers.
• Deep understanding of regulatory requirements in key markets (EMEA, APAC, USA) and of the clinical trial technology landscape.with a solid understanding of clinical development and trail execution
• Excellent drug development, regulatory affairs (pertinent to digital therapeutics) and medical affairs operational knowledge. Previous track record of success in driving innovation in clinical trials and digital health outcomes, including electronic patient reported outcomes (ePRO)
• Strong leadership, negotiation and project management skills with ability to prioritize across multiple competing tasks and objectives
• Good interpersonal and communication skills for linking between scientific and business participants, for driving a program to implementation and for balancing collaborations.
• Ability to think critically and strategically about challenges in design and delivery, and proactively implement solutions to overcome them
• Proficiency in English (oral and written)

Nice to have:

• MBA or PhD in a relevant field

Why consider Novartis?

799 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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326388BR

Development Unit Digital Endpoints Lead

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