Therapeutic Area Biomarker Lead

Summary

Location: Cambridge, MA About the role: As a Therapeutic Area Biomarker Lead (TABL) for the renal and/or global health (malaria, leishmaniasis, dengue and Chagas) portfolios, you will lead the renal and global health disease area matrix teams of Biomarker Leads (leading at clinical project level) and subject matter experts. 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 >100 associates who deliver innovative biomarker solutions for clinical studies. BMD Associates span Subject Matter Experts across the spectrum of biomarker modalities including imaging, digital, soluble/cellular/molecular, and data analytics working in partnerships with the therapeutic area (TA) matrix teams in BMD to develop, communicate and implement biomarker, translational science and translational data strategies with the clinical teams and decision boards.

About The Role

Key Responsibilities:

• Developing and implementing of “fit for purpose” biomarker strategies and providing an effective interface for transitioning projects from early to later stage clinical development. Engaging in translational data science activities and providing therapeutic area line function review for clinical protocols. Leading efforts to identify, develop, and drive disease, mechanistic and compound biology that serves the clinical and precision medicine approaches for the multi-indication renal and global health portfolios.
• Acting as BMD strategic and scientific leader at disease/therapeutic area level to lead biomarker, strategies and plans, translational data, and precision medicine approaches for their portfolio.
• 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 selected clinical projects to drive biomarker and precision medicine strategy at the compound level.
• Representing BMD on disease area and decision boards, and clinical protocol review for their projects.
• Engaging in translational data science activities and providing therapeutic area line function review for clinical protocols. 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 groups 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 our large and diverse clinical portfolio.
• Ensuring alignment within the Biomarker Leads across assets, indications, and therapeutic areas. Is responsible for the contextualization and interpretation of the biomarker data.
• 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 and data for their respective disease areas or indications.
  
  

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $166,400 - $249,600 /year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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 5 years of deep understanding and experience working in biology and translational research of renal diseases and/or global health diseases such as malaria, leishmaniasis, dengue and Chagas, or related biological areas such as inflammation that can be applied to questions of patient’s selection, enrichment, dose selection, efficacy and response, disease progression, among others. PhD, MD, PharmD or MD/PhD degree
• Scientific excellence supported by academic and/or industry career track, and/or high-quality publications; clinical and/or biological expertise in renal, global health or inflammatory diseases.
• Significant proven experience after your MD/PhD/postdoc including drug development, clinical research, or translational research.
• Experience and familiarity with quantitative research and data is strongly preferred, including expertise in biostatistics, bioinformatics, computational biology, clinical imaging, machine learning, genetics, proteomics or data science.
• Proven success in leading and partnering in multidisciplinary matrix teams across Pharma/biotech, academic institutions, or commercial business functions.
• Well-developed interpersonal and leadership skills with strong presence and ability to influence and navigate large organizational structures.
  
  

Desirable Requirements

• Industry experience is strongly preferred.
  
  

Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

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