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Evidence Generation Head IMI, GCC

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Novartis

2mo ago

  • Job
    Full-time
    Junior & Mid Level
  • Research & Development
    Healthcare
  • Dubai
    Remote

AI generated summary

  • You must have an MD, DO, or PhD in health sciences, RWE research experience, strong understanding of medical affairs, and fluency in English and Arabic.
  • You will design and implement RWE programs, lead collaborations, manage data generation projects, support evidence planning, and oversee partnerships across the GCC region to enhance drug development.

Requirements

  • MD, DO or PhD degree in health sciences required, as per GULF & SAUDI strategy and/or local regulations, Msc in healthcare research, MBA in healthcare management and leadership
  • Fluent in English (oral and written), Arabic (native) GULF & SAUDI country language preferable.
  • Preferred Master or Ph.D degree in relevant discipline including health economics, epidemiology, health services research, biostatistics, or public health etc.
  • 1-3 + years conducting RWE research for pharmaceutical products in the pharma industry, contract research organization, or academic institute; or experience in a closely related discipline within the pharma industry (e.g., clinical research, statistics, epidemiology, pricing)
  • Good understanding of Medical Affairs, Drug Development, Market Access/ HEOR, Safety or related disciplines to generate value evidence from retrospective and prospective studies.
  • Experience in planning, creation, and analysis of real- world data, from both prospective and retrospective studies with a proven success record in this field
  • Good understanding of available and emerging RWD data sources.
  • Strong collaboration and networking skills to foster productive internal relationships cross-functionally
  • Fluent oral and written English and Gulf speaking language

Responsibilities

  • Identify and implement innovative RWE programs that can support to overcome key challenges in drug development using RWD or enable to provide meaningful RWE in support of regulatory decision making (e.g. label changes, new indications) across priority disease areas in the Innovative Medicines GCC Organization
  • Identify and implement innovative RWE programs to support payer decision making and maximize the probability of success for the reimbursement. Co-design and execute implementation research to maximize adoption of Novartis medical innovations in line with the needs of patients and healthcare systems.
  • Lead the Implementation science program Ex: Population Health models implementation across the GCC Cluster
  • Map/license RWD sources and build research collaborations to increase the availability of fit-for-purpose RWD. Implement the RWE plan and execute RWE projects timely in close collaboration with cross-functional Partners
  • Support all teams in the integrated evidence planning design and revisiting along with tracking of deliverables
  • Support the access team in initiated research and external HEOR partnerships along with supporting in evidence generation through cost-effectiveness models
  • Serve as franchise/division level RWE Head to ensure a broad understanding of the value of RWE to the product value demonstration both locally, regionally and globally. Serve as franchise/division level RWE expert on all real world evidence generation processes, methods and analytic projects.
  • Lead the Evidence Taskforce across the APMA region with regular meetings and contact with regional and global evidence teams as well as medical affairs leads and directors.
  • Develop product or disease area RWE strategy and plan with the cross-functional team as critical component of local and global integrated evidence plan to be part of the Launch Plan.
  • Plan, initiate, manage the implementation and drive timely publication of Local data generation activities both in Gulf & Saudi CPO.
  • Responsible for local data oversight of adverse event reporting into adherence to GCP, and in line with ICH and local regulations.
  • In collaboration with Clinical Operations team /medical Affairs team, advise / recommend potential investigators for local and global RWE ensuring the right mix of KOLs in Gulf & Saudi CPO.
  • Lead the external partnerships teams in data generation and collaboration on digital platforms and common data models for the external accounts as well as supporting in external capability building delivery as part of signed research MOUs.
  • Manage external teams of statisticians/programmers and other experts, external vendors as needed, and/or research collaborations with Providers or Payers to deliver on research needs.
  • Review vendors quality indicators and support in vendors approval as well as continuous communication along the study stages
  • Lead the development of new and innovative partnerships with external stakeholders across healthcare ecosystems to co-design and execute innovative study designs and implementation science that address pre identified evidence needs.
  • Communicate scientifically valid and relevant RWE to proactively address the varying evidence requirements of stakeholders e.g. Medical Societies, HCPs, Payers, Regulators, Patient Groups.
  • Contribute to the continuing education of relevant line functions / cross - functional team e.g. Medical affairs /patient access on the state-of-the-art RWE designs and methodology. This is done through the capability building curriculum in research and evidence generation.
  • Support in all the stages of the research project including concept sheet writing, protocol writing and review, ICF and eCRF review, presence in site selection and site initiation visits as well as monitoring and tracking from the start of the recruitment until the review of the final report and publication
  • Design and implement concepts for implementation studies research designs
  • Support in site management for locally and globally lead studies in the GCC Cluster
  • Manage the Evidence Team and function: regular support and leadership of the local research team including operations and governance lead and clinical research associates (permanent and on assignment)
  • Local Data generation across different Therapeutic areas
  • Partnership with Health authorities, scientific societies and TMEs
  • RWE Capability building (internal & External)
  • In compliance with local functional business requirements in term of KPIs.
  • Implementation Science (local, regional and global collaboration)

FAQs

What is the primary responsibility of the Evidence Generation Head IMI, GCC?

The primary responsibility of this role is to plan, design, and execute Real World Evidence (RWE) studies across the GCC cluster to develop and demonstrate the value of Novartis marketed and pipeline products to payers and clinicians.

What qualifications are required for this position?

A MD, DO, or PhD degree in health sciences is required. Preferred degrees include MSc in healthcare research or an MBA in healthcare management and leadership.

What type of experience is preferred for candidates applying to this role?

Candidates should have 1-3+ years of conducting RWE research in the pharma industry, contract research organization, or academic institute, or experience in a closely related discipline such as clinical research, statistics, epidemiology, or pricing.

Is knowledge of local languages necessary for this position?

Yes, fluency in English (oral and written) is required, and knowledge of Arabic or other Gulf country languages is preferred.

What kind of collaboration is expected in this role?

The role involves collaboration with cross-functional partners, including supporting various teams in integrated evidence planning and working with external partnerships to enhance research capabilities.

What is the expected location for this role?

The position is based in Dubai, United Arab Emirates.

How does this role contribute to the Medical Affairs team?

The Evidence Generation Head serves as a franchise/division level RWE expert to ensure a broad understanding of the value of RWE and supports the access team in initiating research and external HEOR partnerships.

Are there any specific accountabilities related to safety in this role?

Yes, the Evidence Generation Head is responsible for local data oversight of adverse event reporting, ensuring adherence to GCP, ICH, and local regulations.

What are the key performance indicators (KPIs) for this position?

KPIs include local data generation across various therapeutic areas, partnerships with health authorities and scientific societies, RWE capability building, and implementation science collaborations.

What types of studies will the Evidence Generation Head be involved in?

The individual will be involved in planning, initiating, managing, and publishing local data generation activities and implementing innovative RWE programs to support payer decision-making.

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Novartis

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. Around 108,000 people of more than 140 nationalities work at Novartis around the world.

Culture & Values

  • Inspired

    Engage our people. Strive for patients. Live our purpose

  • Curious

    Learn. Be open. Be self-aware

  • Unbossed

    Create clarity. Serve others. Own your actions

  • Integrity

    Be honest. Have courage. Do what’s right