Biomarker Therapeutic Area Head - Neuroscience

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.

Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology. As a global company, the resources and opportunities for growth and development are plentiful including global and local cross functional careers, a diverse learning suite of thousands of programs & an in-house marketplace for rotations & project work. With strong medicines pipeline our current transformation will not just deliver growth for our business but continue to allow us to bring innovative medicines to patients quickly. Biomarkers are critical components of translational research, enabling robust therapeutic and mechanistic hypothesis testing in early clinical development, and as precision medicine enablers e.g. defining patient subpopulations, predicting patient responses, and use as diagnostics. The Therapeutic Area Head (TABH) in Biomarker Development (BMD) in Translational Medicine, partners with other Disease area, Translational Medicine, Global Development, and Commercial leadership for the development and implementation of innovative, complex, exploratory biomarker strategies, independent of clinical program stage, and provides an effective interface for transitioning projects to later stage development. The BMD TABH leads 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.

• PhD and/or MD desirable with broad biology/technology knowledge in the clinical biomarker field; medical and/or clinical genetics experience desired

• Deep expertise in drug development

• Substantial impactful experience working in Pharma and/or biotechnology R&D; business functions, leading internal and external high performing diverse teams and matrix organizations

• Scientific excellence and clinical expertise in neurodegeneration, neuroimmunology, neuromuscular and neurogenetic diseases/biology evidenced by significant contributions to the field

• Demonstrated technical and scientific expertise in multiple areas for development of innovative biomarker solutions with experience in working across key modalities (eg xRNA, AAV, biotherapeutics and small molecules)

• Well-developed interpersonal skills with good presence and ability to influence and negotiate with senior leadership, experienced presenter and communicator

• Strong track record of people leadership

• Recognized internally and internationally externally by key stakeholders; in depth understanding of external environment/trends; develops a strong professional network

• Fluent in oral and written English; other languages e.g. German, French, Italian useful but not required