Job Description

100,000+ That\'s how many patients participate in our clinical trials at any given time.

The Digital Endpoint Capability Centre (DECC) is recruiting for a Digital Endpoint Lead to drive the strategy and take ownership of developing clinical endpoints using Digital Health Technologies across the Global Drug Development (GDD) function in Novartis. The DECC supports various therapeutic areas across Immunology, Cardiovascular, Neuroscience and Oncology disease areas. You will work alongside experts both within the DECC and with our stakeholders to make this a reality.

The successful candidate will be responsible for elevating Digital Endpoints within Novartis\' clinical trials through partnering with program teams. Working cross-functionally to find opportunities where Digital Endpoints can make valuable contributions to our programs and, subsequently, implement these strategies. You will provide in-depth knowledge of established Digital Endpoints / clinical outcomes assessments and bring external domain knowledge on novel endpoints using digital health technologies that are relevant for Novartis. The Digital Endpoint Lead will work with internal and external partners to advance the use of digital endpoints in clinical development and work towards their acceptance with regulators, payers and the scientific community.

This position is open to applications in the UK & Ireland. Please note that it is a Home Working position in the UK and Hybrid in Ireland.

Your responsibilities:
Your responsibilities include, but are not limited to:

• Define Digital Endpoint strategies with cross-functional teams to elevate the use and impact of digital endpoints (DE) /digital health technologies (DHT) to meet the needs of clinical development within Novartis.
• Drive the elicitation of clinical needs, identify opportunities for DE and systematically assess the value/benefit for clinical programs across therapeutic areas through partnering internally and externally, including capturing/defining the meaningful aspects of health, concept of interest, context of use, etc.
• Provide expert advice to clinical teams on the implementation of DHT in Novartis-sponsored clinical trials, taking into account therapeutic area, phase of development, regulatory jurisdiction and clinical feasibility
• Engage end-to-end with the clinical teams for the effective integration of DE into clinical studies ranging from trial designs, analyses and anchoring through to providing significant contributions to interactions with health authorities (e.g. FDA, EMA) and payers
• Partnering with key internal partners including the Patient Reported Outcome CoE, Regulatory Affairs, Patient Engagement, Value and Access, Quality, IT, Procurement and others to enable holistic and cross functional support to elevate DEs
• Work with the team to identify and manage risks/issues in the deployment of DE/DHT in global clinical trials.
• Leads operational excellence and training initiatives to improve the DECC.
• Responsible for initiating and driving projects and initiatives to ensure the best practice adoption of DE across Novartis
• Represent the team externally in consortia and contribute to guidance\'s relevant to DE/DHT.

Minimum requirements

• Advanced Degree in Life Sciences, Engineering/Technology, Outcomes Research, or a related discipline ideally with a solid grasp of both clinical development and digital health technology.
• Passion for advancing the use of digital technologies in clinical trials/clinical practice, particularly for elevating clinical endpoints using DHT in drug development.
• Previous experience in clinical outcomes assessments, interactions with health authorities (FDA, EMA) on novel endpoints, familiarity with the relevant regulatory guidance\'s on DHT, patient focused drug development would be a distinct advantage.
• Excellent interpersonal, communication, presentation and report writing skills.
• Strong stakeholder management skills, particularly in a matrix environment.

You\'ll receive:
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

Why consider Novartis?
236 million. That\'s how many lives our products touched in 2022. 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!

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

Novartis Ireland Ltd. has been certified as a Top Employer 2022 by the Top Employers Institute for its exceptional employee offerings!

#LI-Hybrid = Novartis

Functional Area

Research & Development

Division

Global Drug Development

Business Unit

DATA & DIGITAL GDD

Employment Type

Regular

Commitment to Diversity & Inclusion:

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

Shift Work

No

Early Talent

No

Novartis