Summary

Focus on optimizing patient access and outcomes by providing up-to-date compound and disease area medical expertise, acting as a key expert in the relevant therapeutic area (Hematology), and leading across functions to address external and internal stakeholder needs. To shape and implement the Local and Global Therapeutic Area strategy through innovative integrated evidence generation, engagement on scientific results with internal and external stakeholders, and co-creation with healthcare systems and the scientific community. To co-design clinical development launch and life cycle management of the drug in close collaboration with Country, Regional, and Global team members. To ensure that the best interest of patients and those who care for them are identified and met.

• Medical strategic Plans
• Prepares and drives the execution of the local Medical Affairs strategic plans aligned and in collaboration with other functions. This plan should be built based on local stakeholder needs and in line with the Franchise and medical strategies as outlined in the Integrated Product Strategy (IPS) Plans.
• Lead early identification of strategic drivers, elaboration of patient journey, positioning, target population, the wider stakeholder population mapping and segmentation.
• Identifies opportunities for joint value creation through engagement with the key scientific leaders and other partners in the healthcare systems including Patients and Patient Associations to co-design strategies and studies, advocating in the assigned therapeutic area. Utilizes omnichannels where possible
• Gathers and internally shares relevant captured insights (advisory boards, events etc), to shape the disease area strategy.
• Integrated evidence co-development
• Accountable to Co-developing integrated evidence plans and ensuring local execution of these plans beginning at DDP/POC and throughout the lifecycle in partnership with Global Drug Development (GDD), functional partners, healthcare systems, patients and other external stakeholders.
• Identifies Real World Evidence (RWE) needs and utilizes implementation science and other innovative methodologies, to close the gap ensuring patient and clinical adoption and better outcomes. Responsible for local and global evidence generation submissions
• Leads the Post Trial Access (PTA) and Managed Access Programs (MAP) at local level, evaluates Investigator-Initiated research studies and Trials (IITs) and Research Collaborations (RC) for scientific soundness and alignment.
• Medical expertise provisions
• Provides key medical expertise on the company's pipeline programs, disease areas and approved brands. Performs comprehensive evaluation of related products passing DDP/FDP to enable effective cross-functional New Product Planning for the Country IM Organization. Provide informed input to Global strategies, protocols, etc if assigned early product portfolio.
• Raises awareness of Novartis' brands, programs, and disease areas through publication of manuscripts, scientific presentations, projects and educational trainings as well as acts as company ambassador in external scientific programs and congresses.
• Provides medical expertise and leadership to functional partners through the life of the product(s) by:
  • Working as a strategic partner in collaboration with, Clinical Research Medical Advisors (CRMA), Marketing, Value Access and Commercial Development (VACD) Patient Advocacy, Public Affairs and GDD teams, where necessary, to ensure effective patient outcomes and access.
  • Co-creating, and along with project owner, ensuring that all Medical and Promotional activities and materials are compliant to Novartis and Pharmaceutical Industry procedures, and to National laws and regulations.
  • Supporting and partnering on training activities to Commercial, Clinical Research Associates (CRAs), Clinical Study Managers (CSMs), etc
  • Supporting Drug Regulatory Affairs (DRA) team on regulatory documents, filing and health authorities' interactions.
  • Key role in governance of external funding, advisory boards, HCP/ HCS engagements and patient support programs.
  • In collaboration with ERC responsible for the alignment of local Medical Affairs compliance initiatives, policy interpretations, risk mitigation, trainings, and corrective actions related to medical.
• Represents those who practice medicine and brings an understanding of how patients are cared for into the work of their therapeutic area, ensuring that activities are in the best interest of patients and those who manage them.
• Ensures Target Patient Population Outcomes (TPOs) are updated and relevant, and that they are being tracked, resourced and impacted at Country IM Organization level with appropriate regional and global support

• Works within Ethics & Compliance policies -Achievement of annual targets for medical activities

• MD or PhD/PharmD in Health Sciences (requirement as per country strategy and/or local regulations)
• Desired: Specialist Degree or specialist qualification related to discipline for which is responsible. Business degree (e.g. MBA)

• English: fluent spoken & written
• Local language: preferable (requirement based on country needs)

• Pharmaceutical industry experience
• Significant clinical and research background GCP
• Strong medical and scientific bases and agility to transverse the diseases' arena
• Good planning and organisational skills
• Strong business acumen
• Strong communication skills and customer orientation
• Strong medical and scientific writing skills
• Preferred experience in innovative study designs e.g. RCT/RWE mixed designs
• Preferred experience in implementation science
• Preferred proven track record of co-creation and co-execution of protocols with stakeholders in healthcare systems