Mar 15, 2022

Job Description

2005! That’s the year that Novartis began exploring Precision Medicine to extend and improve the lives of patients, by enabling the regulatory approval and commercial sale of transformative therapies.

Precision Medicine (PM) is an approach for prevention, diagnosis, treatment, and monitoring of disease that considers individual variability in biology, environment, and lifestyle for each person (source: NIH). Patient biomarker data and diagnostic assays drive healthcare decision-making by helping physicians identify patients for the right treatment and monitor their disease. Beyond biomarkers and companion diagnostics, precision medicine supports the Novartis pipeline by facilitating clinical trial design and execution, accelerating drug development, and informing early pipeline choices. By using advances in biology, technology, and data & digital solutions, Novartis Precision Medicine continues to innovate in our quest to disrupt treatment paradigms and reimagine medicine.

The overall purpose of the GBDL role is to develop and drive the integrated, end-to-end Precision Medicine (PM) strategy for a Disease Unit (DU) and/or Disease Area (DA). The main focus of this role will be responsible for Immuno-Oncology, for Breast and other solid tumors.

Your predominant responsibility will be to integrate and hold accountable the cross-functional Global Biomarker Diagnostic Team (GBDT), made up of colleagues from NIBR (research), GDD (development) and OBU or Pharma (medical affairs & commercial) with the core objectives to drive a seamless end to end biomarker / precision medicine strategy and lifecycle from early clinical stage to adoption in clinical practice

You will work different levels of expertise across the breadth of the drug development continuum, covering clinical development and commercialization processes of precision medicine (i.e. translational science in support of clinical studies to clinical biomarkers and Dx).

You will be a strong influencer and connector across the matrix and lead internal and external stakeholders in the design and delivery of a biomarker and diagnostic strategy for one or more Novartis medicines along the drug development continuum by applying effective team leadership and strategic thinking skills.

Your responsibilities include, but are not limited to:
• Accountable for one or more of the cross-functional Global Biomarker Diagnostic Team (GBDTs) in support of drug development, leading the co-creation of an E2E Precision Medicine strategy for a pipeline of assets within their specific portfolio, integrating and representing equally multiple dimensions involved (NIBR, GDD and OBU) and representing GBDT at the GPTs

Matrix leadership:
• Strong influencer and connector across the matrix managing stakeholders at all levels of the organization and deliver on the Novartis enterprise requirements
• Ensuring integration of all precision medicine factors at GBDT as appropriate
• Build connections across GBDT group to promote transparency, collaboration and sharing of best practices

Deliver the following through integrating, leading and holding the GBDT accountable on biomarker PM approaches:
• Design and drive E2E biomarker strategy to ensure alignment around scenario planning and collaboration across functions
• Be a bridge between GPT and NIBR teams for biomarker related activities, including robust biomarker data strategy, to ensure clinical biomarkers, pharmacodynamics and translational research are designed and implemented at DA-level
• Efficient communication of biomarker strategy developed by the GBDT to the drug development teams (EPT, GPT, clinical) and relevant governance boards to drive alignment and inform decision making for current and future drug development
• Drive scientific publication, internal education and external collaborations and communications to support DA activities
Lead design, development and registration of Dx tests, once need has been identified, by: Additionally, when a known or potential Dx need has been identified:
• Leading all aspects of the design of the diagnostic target test profile (DxTTP), the key claims portfolio and the platform strategy taking into consideration development, regulatory and commercial/consumer requirements/needs that overall lead to a new diagnostic test.
• Drive synergies between NIBR, GDD and OBU through early alignment around DxTPP, partner, assay and technology choice and incorporates Dx budget into overall clinical program budget to allow for at risk investment for more than one testing modality
• Coordinate the development and global registration of Dx assays in support of the drug development strategy and timeline.
• Ensure the delivery of a robust Diagnostic Playbook which will be the foundation for PM launch readiness (including biomarker data package to support launch messaging and handoff to OBU / Pharma)

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• Education (minimum/desirable): PhD, MD or MD/PhD with a Residency (or equivalent) in a general medical field with additional subspecialty training, preferably in Oncology, Molecular Pathology, or Lab Medicine. Experience in Breast Cancer and Immuno-Oncology (IO) would be an asset.
• Minimum 10 years’ experience in Biomarker/correlative analysis and Dx development of which a minimum of 7 years must be in Pharmaceutical and/or Biotechnology industry
• Advanced understanding of drug discovery and development, in depth Precision Medicine and Diagnostic development knowledge, significant experience working in a regulated environment, with an established track record of scientific leadership and developing future precision medicine leaders.
• Strategic and analytical thinking to diagnose and solve complex business problems using lifecycle lens on issues
• Proven strategic skills and business understanding, combined with a drive for implementation.
• Strong leadership skills with experience in building trust and managing relationships in high-pressure environment
• Ability to lead and mentor associates with a broad range of expertise/experience
• Known for strong collaboration and networking with the broader business community and other stakeholders
• Ability to work on multiple projects and under strict deadlines; has a sense of urgency. With excellent oral/written/presentation communication skills
Global Drug Development
Research & Development
Full Time
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Global Biomarker Diagnostic Lead, (Immuno-Oncology)

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