摘要
Biomarkers are critical components of Translational Research and Medicine, enabling robust therapeutic and mechanistic hypothesis testing in early and late clinical development. As precision medicine enablers, biomarkers describe disease heterogeneity, define patient subpopulations, predict therapeutic response, and can ultimately serve as diagnostics.
As a BML in BioMarker Development (BMD), you are accountable for defining and delivering biomarker strategies for the Immunology portfolio across multiple drug development programs in early and late clinical stages. You are accountable to translate the preclinical mechanistic understanding into an indication-relevant biomarker strategy, a clinical fit-for-purpose biomarker plan, oversee the integration into the clinical protocol, and lead the scientific and strategic discussions in project teams and governance meetings. As such you are a core member of project teams, lead Biomarker and Diagnostic SubTeams (BDST), engage in Translational Data Science teams, and provide scientific, strategic, and tactical input aligned to the portfolio.
Position to be based in London, UK. Hybrid work model.
Position to be offered commensurate with candidates' level of experience.
About the Role
Major Accountabilities (Core Responsibilities)
- BMD scientific, strategic and tactical leader at project level driving impactful biomarker strategies and supporting biomarker plan excellence with concise communication in project teams and governance meetings.
- Accountable for the biomarker strategy at a project, indication and study level in coordination with the respective clinical study lead and biomarker study expert.
- Lead the BDST to align key stakeholders on the biomarker strategy and biomarker plan at the project and study level and across the portfolio.
- Accountable for the concept, endorsement, implementation, delivery and contextualization of the biomarker strategy.
- Contextualizes biomarker results and disseminates conclusions to external audiences via abstracts and/or peer-reviewed publications.
- Represents BMD line functions in Therapeutic Area Line Function committees for clinical protocol development and operational milestone reviews.
- Reports to the Therapeutic Area Biomarker Head (TABH) or Therapeutic Area Biomarker Lead (TABL) and cooperates closely to enable the project/study level biomarker strategy at concept and contextualizing stages.
- Aligns with the TABH and TABL to deliver on BMD TA strategy and initiatives.
- Co-leads strategic translational data science working groups focused on integrating large-scale patient data sets to identify novel indications, patient subgroups, and endpoints to enable decision-making and responder patient subpopulation identification in clinical trials.
Education & Experience.
• MD, MD/PhD, or PhD degree required, plus additional PhD/postdoc or equivalent level research
• Scientific excellence, or clinical expertise in immunological diseases/related field, or leadership and expertise evidenced by previous role in the translational and biomarker spaces
• Experience in industry (Pharma or Biotech) for at least 5 years.
• Relevant expertise utilizing biomarkers for clinical decision-making including pharmacodynamics, clinical efficacy, disease deconvolution, response characterization, patient stratification and/or precision medicine
• Evidence of interpreting and disseminating omics related findings, e.g. genetics, genomics, proteomics, with relevant application to clinical decision making while partnering with key stakeholders from research, data sciences and clinical development.
• Understanding of integrating a variety of biomarker modalities, and experience interacting with the various stakeholders within the organization to ensure timely execution of plans and feasibility of implementing the proposed strategies in the clinical studies.
• Proven success in leading matrix (global, cross functional) teams including well developed interpersonal, communication (oral and written) and influencing skills
• Creative and innovative leadership with a sharp and objective intellect, and experience in balancing big picture thinking with detailed analysis
• Demonstrated passion for science, seeking out new clinical discovery opportunities and early clinical study approaches and ability to leverage KOL’s in the field.
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
