Digital Strategy Lead, Clinical Trial Innovation – USCDMA
Sandoz International GmbH
US GEN MED East Hanover, NJ Research & Development Regular
vor 8 Tg.


Digital Strategy Lead, Clinical Trial Innovation USCDMA

Job Description

Digital Strategy Lead, Clinical Trial Innovation USCDMA

Explosive growth in digital technologies and sensors converging with access to big data and machine learning creates a special opportunity to be on the forefront, and help lead, where Novartis US Clinical Development & Medical Affairs (US CDMA) is heading.

The heat is on - in driving digital & innovative transformation in late phase US clinical trials; this unique, high-impact, high-

visibility role has the potential to make a huge impact to improve the lives of patients, and break ground for where we are heading.

Job Purpose

Within US Clinical Development & Medical Affairs, serve as a strategic Digital & Innovation Lead focusing on expanding digital capabilities and innovative processes in support of our Clinical Trial Programs in various stages of development (Phase III -

IV trials and HEOR studies) in partnership with teams across the enterprise.

Major Activities

Responsible to USCDMA for collaborating in a matrix-environment across NIBR (Novartis Institute of Biomedical Research), Global Drug Development (GDD), Global Medical Affairs (GMA), and Global Product Teams (GPTs), and with USCDMA HEOR, Clinical Trial Operations, to develop and drive expanded use & adoption of digital capabilities across USCDMA that can maximize the value proposition of our Clinical Trial Programs.

In order to drive digital innovation across our clinical trial programs, proactively identify and continually evaluate emerging external digital health trends, new internal capabilities, start-

up companies, and technology providers across the digital health ecosystem with primary focus on core areas including, but not limited to : (1) identify strategic use-

cases for, and incorporating in, the use of digital sensors and wearables for generation, and evaluation of digital end points, (2) identify and apply artificial intelligence (AI) and ma-

chine learning solutions to optimize clinical trials (i.e., patient identification, recruitment, site selection, etc.), and (3) identify and champion use of digital companion apps and digital therapeutic use-cases.

  • Develop and deliver strategic input for the application of digital technologies into Clinical Development & Medical Affairs clinical trials to ensure implementation across teams / disease states
  • O Identification and implementation of practical applications of digital sensors and wearables into clinical studies (i.

    e., incorporation into protocols), inclusive of providing operational oversight to maximize clinical evidence generation in Phase III & IV programs.

    O Investigate and propose new Digital Endpoints and Digital techniques for assessment of disease severity or symptoms in clinical studies.

  • Identify and implement a data strategies built around Artificial Intelligence (AI) and Machine Learning to optimize clinical trial process including site identification, patient identification & recruitment, protocol feasibility, etc.
  • Evaluate the external digital health ecosystem including start-up companies, to monitor / identify advancements in digital technologies that potentially can be incorporated into USCDMA clinical trial programs.
  • Provide strategic cross-functional leadership by contributing digital health insights into Medical Product Plans with focus on innovating our clinical trial strategy through incorporation of a digital presence, where applicable, with US Medical Units, Early Development, and HEOR.
  • Identify, evaluate and optimize emerging capabilities in partnership with Global Digital functions in Global Drug Development and NIBR
  • Additional responsibilities include the following :

  • Provide strategic digital & innovation leadership support by collaborating with Early Development Medical Directors, HEOR, CRMDs, and Medical Unit Medical Directors, and Patient Engagement group to optimize clinical trial recruitment.
  • Be a positive and strong change agent within USCDMA and the US CPO to continually seek out innovative ways to pragmatically expand USCDMA digital capabilities and been viewed as a digital leader with the organization.
  • Collaborate with US Commercial-Digital Innovation group to ensure applicable alignment of US CPO digital strategy and partner, when applicable to synergize efforts and collaboration.
  • Support USCDMA Digital Strategy & Medical Innovation department / colleagues across a variety of department objectives.
  • Collaborate with USCDMA HEOR to evolve how USCDMA can better leverage big data to optimize clinical trial programs.
  • Key Performance Indicators

    1.Ability to develop and implement digital medical / health strategies based on integrated and synthesized customer & treatment insights to effectively enhance UD CDMA programs

    2.Partner across a large matrix of internal stakeholders (GDD, NIBR, New Products Commercial, US Medical Affairs, Inline Commercial, Regulatory Affairs, Legal, Clinical Operations, Health Economics and Outcomes Research, Market Access and Project Management) to deliver digital medical / health solutions for Clinical Development, HE&OR, and phase 4 programs

    3.Successful and meaningful implementation of digital sensors and other technologies across clinical trial programs

    4.Viewed as a key partner to the US, Global and NIBR organization

    5.Through ongoing and planned digital initiatives, enhances Novartis’ digital skill set

    6.Identification, evaluation, and incorporation (where applicable) of emerging technologies and digital trends into our clinical trial programs.

    7.Ability to communicate effectively, manage issues, resolve conflicts, and mitigate risks

    8.High-display of Novartis Values & Behaviors

    9.High-agility to pivot and take new direction as it relates to department strategy

    EEO Statement

    The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

    Minimum requirements

    Position will be filled at level commensurate with experience.

    Education (minimum / desirable) :

    Health related degree with Pharma experience. MD, DO, PhD or PharmD preferred, but not required.

    Experience / Professional requirement :

  • Minimum of 5+ years of pharmaceutical industry experience required with deep understanding of clinical trials.
  • Required experience in identifying & implementing digital strategies.
  • Strong familiarity within digital health space including strong comprehension of digital sensors, wearables, etc.
  • Proven ability to build and lead highly productive cross-functional relationships and teams internally and externally within a matrixed and resource-constrained environment
  • Proven ability to integrate science / clinical / medical and commercial information to identify, develop and implement digital solutions
  • Project management expertise with recent experience leading large projects / organizations
  • Strong organizational skills and ability to prioritize across competing agendas while managing stakeholders’ needs
  • Proven track record of being an effective, open, available and transparent communicator
  • Excellent oral and written communication skills
  • Experience with Agile Project Management preferred
  • Ability to travel (U.S. and Europe; 15-25% annually).
  • Strongly Desired :

  • Demonstrated experience working with big data, artificial intelligence, and machine learning principles.
  • Track record of providing digital medical input into commercial and medical plans, building digital medical plans and value strategy
  • Documented history of bridging proactive relationships across translational medicine, clinical development, market access, and brand teams
  • A well-established network within the digital medicine / health community
  • Strategy and / or consulting experience
  • Demonstrated capabilities to build relationships with External Medical Experts
  • Why Consider Novartis :

    927 million. That’s how many lives our products touched in 2017. And while we’re proud of that, 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 empowered to ask new questions, make bolder decisions and take smarter risks.

    We are Novartis. Join us and help reimagine medicine.

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