Therapeutic Area Biomarker Lead (Renal, Autoimmune, Genetic diseases)

Band

Level 6

 

Job Description Summary

#LI-Hybrid

Internal Title: Director

About the role:

As a Therapeutic Area Biomarker Lead (TABL), leading areas related to renal biology, autoimmune diseases, genetics diseases and related areas you will lead project matrix teams of Biomarker Leads (leading at clinical project level) and subject matter experts and support clinical projects as the Biomarker Lead. Biomarkers are critical components of translational research, enabling robust therapeutic and mechanistic hypothesis testing in early and late clinical development, and as precision medicine enablers covering the potential contexts of use e.g. confirm target engagement and pathway modulation, assess efficacy and response, PD/PK and dose selection, safety, disease modification, patient selection or stratification, and compound differentiation that directly support program decision making. The Biomarker Development (BMD), within Translational Medicine in Novartis, is a dedicated group of >150 associates who deliver innovative biomarker solutions for clinical studies. BMD expertise spans the spectrum of biomarker modalities including imaging, digital healthcare technologies, soluble/cellular/molecular, data analytics and operations working in partnerships with the therapeutic area (TA) teams to develop, communicate and implement biomarker, translational science and translational data strategies and plans with the clinical teams and decision boards.

 

Job Description

Key Responsibilities:

• Acting as BMD’s strategic and scientific leader of the renal portfolio and exploratory disease area (DAx, covers kidney, liver and fibrosis themes) to lead fit for purpose clinical biomarker strategies and plans, translational sciences, data, and precision medicine approaches for their portfolio in partnership with key stakeholders including clinical development, research, and other translational medicine functions.
• Leading efforts to identify, develop, and drive disease, mechanistic and compound biology that serves the clinical and precision medicine approaches for the multi-indication portfolio. Is responsible for the contextualization and interpretation of the biomarker data.
• Leading, where relevant, enterprise cross functional teams and work streams for example around human genetics, translational data, precision medicine etc.
• Leading a dedicated matrixed group of biomarker leads (leading at project level) and Subject Matter Experts, as well as key program partners, to together develop biomarkers strategies for disease and/or assets across the Research-Development-Commercial continuum.
• Acting as Biomarker Lead on clinical projects to drive biomarker and precision medicine strategy at the compound level.
• Representing BMD on decision boards meetings, and clinical protocol review for their projects.
• Developing deep understanding of the translational biomarkers for a project, focused on compound, disease, target, and pathway biology.
• With our data science leads, leading strategic translational data efforts centered on integrating and analyzing large-scale patient muti-modal data sets (omics, imaging, digital, etc.).
• Providing thought leadership with other BMD therapeutic area TABLs to identify alignments and drive innovation across assets, indications, and therapeutic areas.
• Reporting to Therapeutic Area Biomarker Head (TABH) and cooperating closely to enable the development of disease are/indication/project level biomarker strategy and plans, implementation, contextualizing, and interpretation.
• Acting as an enterprise partner and strategic leader in a matrix environment; integrating and representing projects in the internal/external scientific discussions and initiatives.
• Staying up to date on clinical, disease, biology and scientific literature for their respective disease areas or indications.

Essential Requirements:

• This position will be located at the Cambridge, MA site and will not have the ability to be located remotely. This position will require approximately 5% travel as defined by the business (domestic and/or international).
• Minimum 10 years of experience with deep understanding of any of the following areas: renal biology, immunology, auto-immune diseases, genetic diseases or related areas. As well as strong translational research, drug development and clinical biomarkers that can be applied to questions of target and pathway engagement, patient’s selection, enrichment, dose selection, efficacy and response, disease progression, among others. 
• PhD, MD, PharmD, MD/PhD, or equivalent degrees with relevant experience
• Pharmaceutical industry experience strongly preferred.
• Expertise in human genetics and integrative