Evidence Generation Head IMI, GCC

Major Accountabilities:

Expertise and Medical support

• 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

Collaboration

• 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

Global and Regional teams

• 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 medicai affairs leads and directors.

Strategy

• 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.

Local studies and publication

• Plan, initiate, manage the implementation and drive timely publication of Local data generation activities both in Gulf & Saudi CPO.

Safety

• Responsible for local data oversight of adverse event reporting into adherence to GCP, and in line with ICH and local regulations.

Investigators and external partnerships

• 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.

Third party/vendors

• 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

KOLs

• 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.

Communication

• Communicate scientifically valid and relevant RWE to proactively address the varying evidence requirements of stakeholders e.g. Medical Societies, HCPs, Payers, Regulators, Patient Groups.

Training

• 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.

Technical Skills

• 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

Team Management

• 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) ​

KPI's

• 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)

Education

Languages:  Fluent in English (oral and written), Arabic (native) GULF & SAUDI country language preferable.