Medical Advisor Car-t

3 settimane fa

Milano, Italia Novartis A tempo pieno

743 million lives are impacted by us, and as a Medical Advisor CAR-T you will contribute so that our impact continues extending and being a positive factor in many lives.
As Medical Advisor CAR-T you will provide strategic support for profiling assigned marketed compounds and or for developing assigned pipeline compounds. You will provide up-to-date medical expertise, act as a key expert in the therapeutic area assigned and drive Novartis scientific messages to external and internal stakeholder. You will co
- design clinical development launch and life cycle management of the drug in close collaboration with Country, Regional, and Global team members. You will shape and implement the Local and Global Therapeutic Area strategy through innovative integrated evidence generation. You will be responsible for planning and implementation of medical projects/events in accordance to medical strategic plans. You will ensure that the best interest of patients and those who care for them are identified and met.

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

- Strategic: Contribute to development and registration of assigned pipeline products, profiling of new and marketed assigned compounds; medical expertise and support to launches of new products and life cycle management of marketed compounds.
- Operational: Provide medical, clinical expertise and scientific advice to all Line Units in local Country Organization (CO) and to GDD local team.
- Collaboration: Collaborate effectively with:

- CO, Regional and Global GDD and Medical Affairs teams in the execution of relevant clinical activities, and Medical Affairs projects.
- Clinical Research Medical Advisors (CRMA), GDD teams, Marketing, Value Access and Commercial Development, Patient Advocacy and Public Affairs, where necessary, to ensure effective patient outcomes and access.
- CO Marketing, Market Access, Clinical Research Associates (CRAs), Clinical Study Managers (CSMs) and Field Force as scientific specialist and trainer on assigned compounds.
- Regulatory Affairs (RA) team as support for regulatory documents, filing and health authorities’ interactions
- Global/Regional teams: May serve as CO representative on Global/Regional teams.
- Strategy: Contribute with medical and clinical expertise to finalization of GDD trial allocation strategies CO; contribute to strategic alignment of assigned compound(s), in line with the relevant Governance G/R/C. Identifies Real World Evidence (RWE) needs and use innovative methodologies, to close the gap ensuring patient and clinical adoption and better outcomes.
- Clinical studies and publication: For Global and Regional studies, contribute to negotiate the Italian commitment, contribute to planning, implementation and management of assigned clinical studies, driving timely of the relevant clinical and scientific activities, in adherence to GCP (Good Clinical Practice), and in line with ICH (International Conference on Harmonization of the Technical Requirements of Pharmaceuticals for Human Use) and local law. For Local studies also plan, initiate and manage their implementation and drive timely scientific communication/publication of clinical activities including local profiling programs, when applicable.
- Safety: Responsible for local clinical trial oversight of adverse event reporting together with NPS (Novartis Patients Safety) as well as clinical input into adherence to GCP (Good Clinical Practice).
- Investigators/Medical Experts: Advise/recommend potential investigators/Medical Experts for local and global studies and Medical Affairs projects.
- Marketing/Market Access: Function as the medical disease/ product focal point.
- Medical Science Liaison: Work with Medical Science Liaisons proactively to provide scientific support in the Medical Experts interactions for the relevant disease area/product.
- Materials: May create, review, and approve promotional, non promotional and training material tailored to the needs of the assigned compound and according to Corporate policies and local regulations.
- Training: Provide comprehensive compound/disease and therapies presentations and training to internal (i.e. field force) customers and external providers (i.e. local CRO or other external agencies), for the accurate delivery of scientific data in line with global and regional plans.
- Non promotional scientific projects: Responsible for planning and execution of the non promotional scientific events in line with Global/Regional/Local medical plans as well as Patient Supported Programs and Preceptorships.
- Reputation: Maintain ethical standards of CO operations to contribute proactively to a credible reputation for Novartis CO in the local Health Care and Medical community.
- Management: May lead local medical project teams cross-functionally.
- Budget: Responsible for plan and consolidate the assigned budget for Medical Affairs projects.

**Commitment to Diversity & Inclusion**:

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