The role
04Key Responsibilities:
- Key leader to identify, develop, and drive disease, mechanistic biology, translational pharmacology and precision medicine approaches for the Neuroscience and DARe (Diseases of Aging and Regenerative medicine) portfolio, leveraging diverse biomarker modalities e.g. genetics, genomics, proteins, cells, imaging, digital devices and technology/data science strategies
- Strategic decision-making and executive oversight in indication / patient selection, biomarker strategy formulation, and investigations into drug mechanisms of action
- Responsible for delivering clinical project and disease biology “fit for purpose” biomarker strategies/plans across the Neuroscience and DARe (Diseases of Aging and Regenerative medicine) portfolio and leading reviews at Disease Area Decision Boards (DADBs), Biomarker Forum, Biomarker and Diagnostic Review Committee, TDSCs and governance boards
- Leads, mentors and develops a dedicated group of biomarker project team leads (BML) and therapeutic area biomarker leads (TABL) to develop and oversee clinical project strategies, plans and timelines
- Provides Novartis disease biomarker leadership internally and externally to drive innovative mid-long term disease area initiatives/consortium across biomarker/clinical study designs, endpoints, diagnostics and discovery strategies
- Provides insight into optimal selection of exploratory, “fit for purpose” and validated biomarkers (across modalities e.g. genetic, genomic, soluble, cellular, imaging, digital) to address clinical and biological mechanism questions, trial endpoints and identify responsive patient subpopulations
- Works in close collaboration with other functions in Biomedical Research and Development (e.g. TMDP, CSI, PKS, PCS, RA, DDCI, DAs and DUs) to provide expertise, optimize portfolio value and issue resolution
- Responsible for high-quality contributions and review of study protocols, clinical study reports, Integrated Development Plans, and Clinical Pharmacology Plans
- Supports high quality internal and regulatory submissions/decisions e.g. proof of concept/mechanism, dose selection/escalation, safety and competitive differentiation claims
- Attends meetings with external parties including investigators, outside experts, and health authorities, as needed
01Key leader to identify, develop, and drive disease, mechanistic biology, translational pharmacology and precision medicine approaches for the Neuroscience and DARe (Diseases of Aging and Regenerative medicine) portfolio, leveraging diverse biomarker modalities e.g. genetics, genomics, proteins, cells, imaging, digital devices and technology/data science strategies
02Strategic decision-making and executive oversight in indication / patient selection, biomarker strategy formulation, and investigations into drug mechanisms of action
03Responsible for delivering clinical project and disease biology “fit for purpose” biomarker strategies/plans across the Neuroscience and DARe (Diseases of Aging and Regenerative medicine) portfolio and leading reviews at Disease Area Decision Boards (DADBs), Biomarker Forum, Biomarker and Diagnostic Review Committee, TDSCs and governance boards
04Leads, mentors and develops a dedicated group of biomarker project team leads (BML) and therapeutic area biomarker leads (TABL) to develop and oversee clinical project strategies, plans and timelines
05Provides Novartis disease biomarker leadership internally and externally to drive innovative mid-long term disease area initiatives/consortium across biomarker/clinical study designs, endpoints, diagnostics and discovery strategies
06Provides insight into optimal selection of exploratory, “fit for purpose” and validated biomarkers (across modalities e.g. genetic, genomic, soluble, cellular, imaging, digital) to address clinical and biological mechanism questions, trial endpoints and identify responsive patient subpopulations
07Works in close collaboration with other functions in Biomedical Research and Development (e.g. TMDP, CSI, PKS, PCS, RA, DDCI, DAs and DUs) to provide expertise, optimize portfolio value and issue resolution
08Responsible for high-quality contributions and review of study protocols, clinical study reports, Integrated Development Plans, and Clinical Pharmacology Plans
09Supports high quality internal and regulatory submissions/decisions e.g. proof of concept/mechanism, dose selection/escalation, safety and competitive differentiation claims
10Attends meetings with external parties including investigators, outside experts, and health authorities, as needed