Biomarker Lead

Job Description Summary

This is a newly created position regarding the establishment of a clinical translational research hub.
800 biomarker discovery and development projects, across more than 100 clinical studies, which generate 20 petabytes and 2 million patient-years of data! All waiting for you to unlock the next breakthrough in medicine.
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, safety, disease modification, patient selection or stratification, and compound differentiation that directly support program decision making.
Biomarker development (BMD), is part of Translational Medicine in Novartis, is a dedicated group of >130 associates who deliver innovative biomarker solutions for clinical studies across the whole spectrum of modalities (imaging, digital, soluble, cellular, DNA, RNA, data analytics) where line functions and the therapeutic area (TA) matrix team develop, communicate and biomarker and translational strategies with the clinical teams and decision boards.
BMD is expanding in Japan, and we are hiring for two Biomarker Lead (BML) positions. As a BML, you will define the biomarker strategies and plans for a set of programs/projects, defined by asset or by indication, from early to later stage clinical development. You will also build external collaborations with academia or clinical sites to advance the knowledge around translational sciences and biomarker solutions focused on diseases, indications or pathways. The BML will be responsible to translate the preclinical discovery efforts into a clinical fit for purpose plan, as well as develop and mature the clinical biomarker plans as the program progresses through the various phases. The BML will oversee the integration into clinical protocols and lead the review and discussions at the different teams and boards. Finally, the BML can lead a matrixed biomarker team of scientific experts to build on the biomarker strategies and plans.
800 biomarker discovery and development projects, across more than 100 clinical studies, which generate 20 petabytes and 2 million patient-years of data! All waiting for you to unlock the next breakthrough in medicine.
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, safety, disease modification, patient selection or stratification, and compound differentiation that directly support program decision making.
Biomarker development (BMD), is part of Translational Medicine in Novartis, is a dedicated group of >130 associates who deliver innovative biomarker solutions for clinical studies across the whole spectrum of modalities (imaging, digital, soluble, cellular, DNA, RNA, data analytics) where line functions and the therapeutic area (TA) matrix team develop, communicate and biomarker and translational strategies with the clinical teams and decision boards.
BMD is expanding in Japan, and we are hiring for two Biomarker Lead (BML) positions. As a BML, you will define the biomarker strategies and plans for a set of programs/projects, defined by asset or by indication, from early to later stage clinical development. You will also build external collaborations with academia or clinical sites to advance the knowledge around translational sciences and biomarker solutions focused on diseases, indications or pathways. The BML will be responsible to translate the preclinical discovery efforts into a clinical fit for purpose plan, as well as develop and mature the clinical biomarker plans as the program progresses through the various phases. The BML will oversee the integration into clinical protocols and lead the review and discussions at the different teams and boards. Finally, the BML can lead a matrixed biomarker team of scientific experts to build on the biomarker strategies and plans.

Job Description

BML requirements

• PhD, MD, MD/PhD, or MS degree is required.
• Good understanding of biology and translational research that can be applied to questions of patient’s selection, enrichment, dose selection, efficacy and response, disease progression, mechanism of actions, among others.
• Scientific excellence supported by academic and/or industry career track, and/or high -quality publications; clinical and/or biological expertise.
• Significant relevant experience after your MD/PhD/postdoc including drug development, clinical research/development, or translational research.
• Track record of contributions to clinical programs and studies in pharma industry (or biotech) is strongly preferred.
• Experience and familiarity with quantitative research and data is preferred, examples include biostatistics, omics profiling, AI/ML, bioinformatics, computational biology, clinical imaging, machine learning, or data science.
• Proven success in leading and partnering in multidisciplinary matrix teams across Pharma/biotech, or academic institutions.
• Creative and innovative leadership, experience in balancing big picture thinking with detailed analyses and operational aspects.
• Well-developed interpersonal and leadership skills with strong presence and ability to influence and navigate large organizational structures as well connect and network with KOLs.
• Fluent English and Japanese required.

Skills Desired

Data Analysis, Drug Discovery, Hypothesis Testing, Problem Solving, Structural Biology