The senior lead, Precision Medicine Strategy is accountable for building the precision medicine strategy for Novartis’ portfolio of precision therapies (Companion Diagnostics/CDx) from early stage by ensuring that CDx testing is broadly established prior to launch, and CDx test rates and quality continue to be optimized after drug approval. Accountabilities will involve such as (but not limited to) contribution for development of an early product/Medical strategy, an input to local target product profile (TPP), Integrated evidence planning (IEP) development and strategic collaboration with Global Precision Diagnostic team. In particular, the senior lead is required to oversight those strategic plan/execution by considering cross-therapeutic area (TA), and company-wide strategy.
. Lead, develop and execute an early CDx strategy for relevant assets in alignment with Medical lead in Early Medical Strategy (EMS) and/or TA-Medical, GDD(Global Drug Development) and NPP(New Product Planning).
o Comprehensively analyze the patient journey and treatment landscape from the CDx points of view, identify key strategic imperative to be addressed.
o Build and develop sustainable professional relationships with pathologists, molecular biologists and other CDx providers, acting as the face of Novartis via these customers
o Educate CDx providers on the specific CDx requirements of Novartis targeted therapies, providing all necessary clinical and technical information on the stratifying biomarkers incl. testing specifics within Novartis CDx programs and clinical trials
. Ensure Precision Medicine input into local and global One Impact Planning through active collaboration with TA lead, Medical lead and top Medical Experts (ME).
o Bring clarity to key decision making points in development process (e.g. TDP(Transition Decision Points), FDP(Full-development decision point) etc.) based on CDx relevant medical insights
o Input to local TPP optimization
o Contribute to portfolio prioritization and Japan Pipeline Strategy Meeting
o Drive the actionable insight cycle by giving regular clear direction to Japan Program Team(JPT) and Pre-Japan Brand Team(JBT), and utilizing the insights to update the early product strategy
. Develop specific RWE research programs as part of IEP, that can add value for compounds and CDx across the lifecycle and provide scientific expertise and effective project oversight to ensure the successful fulfilment of the RWE projects, being responsible for the conduct, quality, and integrity of RWE studies/analyses and scientific disclosures.
o Plan and execute initial IEP in collaboration with Medical Lead
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Bachelor’s degree, Advanced science degree (MD, PhD,
PharmD, MPH etc) strongly preferred
Fluent in English (business level)
. At least 3 years agile project management in a business.
(Not software) context
. Preferred (not essential).
o Experience in pharmaceutical or diagnostic industry
. 3years on Medical Advisor experience
Practical experience in molecular diagnostics or pathology
. Agile Project Management
. Ability to synthesize complex requirements into clear
. Strong relationship management and natural collaborator
. Cost Management skills
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